FDA Device Registration & Listing · North York Ontario, CA · Registration 3012421607
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-09-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-08-01 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-06-17 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-06-17 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-04-26 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2018-04-26 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-04-02 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2024-11-04 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2025-05-20 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2025-05-20 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2017-04-05 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2020-08-05 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-04-27 |
| NOA | Device, Paste-On For Incontinence, Non-Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2017-10-24 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-16 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2025-01-29 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2026-04-01 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-06-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2023-08-22 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-03-14 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2023-11-20 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2018-05-15 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-24 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-08-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-01-28 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2026-01-28 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2026-01-28 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2025-03-20 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2017-10-25 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-01-15 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2018-04-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-10 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2016-09-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-01-28 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2021-08-27 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2025-04-02 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-03-07 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2017-09-22 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2020-02-24 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2017-02-23 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2017-02-23 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-01-09 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2024-07-29 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2025-07-11 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2024-07-24 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2020-09-24 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2018-04-27 |
| OXZ | Pediatric/Child Facemask | General, Plastic Surgery | Class 2 | 878.4040 | 2025-01-29 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2024-06-05 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-06-05 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2017-03-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2023-05-03 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-05-15 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-07-25 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2024-07-25 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2024-07-25 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2017-02-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-02-22 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2018-05-08 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-07-30 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-05-07 |
| DWJ | System, Thermal Regulating | Cardiovascular | Class 2 | 870.5900 | 2025-12-31 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2026-04-08 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2017-04-05 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-01-29 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2023-05-24 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-04-08 |
| EXI | Device, Paste-On For Incontinence, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2020-02-21 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-17 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2020-04-16 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-23 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-04-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-04-05 |
| KCO | Nasal Spray, Ent Delivery | Ear, Nose, Throat | Class 1 | 874.5220 | 2017-03-14 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2020-04-06 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2016-09-08 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-03-07 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2023-04-11 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-09-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-24 |
| EZQ | Pouch, Colostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2020-01-17 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | Class 1 | 884.1730 | 2023-11-20 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2023-10-06 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2016-09-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2026-02-06 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2023-11-20 |
| EKN | Point, Paper, Endodontic | Dental | Class 1 | 872.3830 | 2017-03-14 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2017-04-05 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2020-01-06 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-23 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2022-08-18 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | Gastroenterology, Urology | Class 1 | 876.5250 | 2022-02-17 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-09-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-08 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-07-17 |
| EHL | Point, Abrasive | Dental | Class 1 | 872.6010 | 2016-09-20 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2022-12-20 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-04-05 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2018-06-06 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2024-03-20 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-03-14 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Anesthesiology | Class 2 | 868.5150 | 2022-04-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-09-28 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2016-09-19 |
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-04-23 |
| NGT | Saline, Vascular Access Flush | General Hospital | Class 2 | 880.5200 | 2022-03-08 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-28 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2021-01-08 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | Physical Medicine | Class 1 | 890.5710 | 2022-04-26 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-09-17 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2025-08-01 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2024-03-18 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2024-10-21 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2026-01-12 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-04-27 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-16 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-07-18 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2024-07-18 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-24 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2024-12-09 |
| NZW | Heparin, Vascular Access Flush | General Hospital | Class 2 | 880.5200 | 2024-12-31 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2025-12-02 |
| MOQ | Battery, Replacement, Rechargeable | General, Plastic Surgery | Class 1 | 878.4820 | 2017-03-20 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-19 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2022-01-14 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2019-02-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-02-08 |
| EXE | Protector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-04-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-13 |
| DZB | Headgear, Extraoral, Orthodontic | Dental | Class 2 | 872.5500 | 2018-05-08 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-05-27 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2017-02-23 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2020-03-23 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2020-10-23 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2022-03-28 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-05-01 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-02-08 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2017-03-20 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2021-11-29 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-09-23 |
| EEG | Heat Source For Bleaching Teeth | Dental | Class 1 | 872.6475 | 2017-09-22 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2017-10-24 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2018-05-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2022-05-10 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-08 |
| KCQ | Tube Impression And Matrix | Dental | Class 1 | 872.6570 | 2025-07-11 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2025-05-20 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2023-11-20 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2022-09-29 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-09-18 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-04-27 |
| HBA | Neurosurgical Paddie | Neurology | Class 2 | 882.4700 | 2020-01-06 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-06-10 |
| KZF | Device, Medical Examination, Ac Powered | General Hospital | Class 1 | 880.6320 | 2017-03-20 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2025-12-19 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2020-04-30 |
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-04-03 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2017-03-14 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-09-08 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2017-04-05 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2024-07-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2024-09-25 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2022-11-08 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2017-10-25 |
| ELY | Mercury | Dental | Class 2 | 872.3070 | 2017-10-25 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2017-10-25 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-05-07 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-09-03 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2024-07-22 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-08-19 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2024-08-19 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2017-04-05 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2020-02-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-02-23 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-01-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-06-17 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-06-17 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-04-05 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2024-07-15 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-06-06 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2018-06-06 |
| MDB | System, Blood Culturing | Microbiology | Class 1 | 866.2560 | 2024-08-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-01-24 |
| EKK | Spreader, Pulp Canal Filling Material, Endodontic | Dental | Class 1 | 872.4565 | 2017-03-14 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2019-12-23 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-08 |
| EAT | Tester, Pulp | Dental | Class 2 | 872.1720 | 2017-04-05 |
| LFC | Device, Caries Detection | Dental | Class 2 | 872.1740 | 2017-02-22 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2021-11-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-19 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2017-04-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-08 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2023-03-10 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-11-13 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2017-07-07 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2016-09-19 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2017-09-22 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2024-05-27 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-05-27 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2024-05-27 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2024-05-27 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2024-05-27 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2024-05-27 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2024-05-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-03-13 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-23 |
| DQD | Stethoscope, Electronic | Cardiovascular | Class 2 | 870.1875 | 2018-03-15 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-23 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2020-03-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-02-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-08-03 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-05-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-10-25 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2016-09-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-08 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2016-09-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-09-05 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-04-02 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2025-04-02 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2020-02-21 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2017-02-23 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2017-04-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-01-24 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-01-14 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2017-03-21 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2018-05-15 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | Class 1 | 880.6150 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-25 |
| KOJ | Airbrush | Dental | Class 2 | 872.6080 | 2018-04-27 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-04-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2023-12-07 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-04-01 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-04-01 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-03-11 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2025-06-17 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-04-05 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-09-03 |
| DYW | Bracket, Plastic, Orthodontic | Dental | Class 2 | 872.5470 | 2019-10-18 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2019-10-18 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2019-10-18 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-05-20 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-07-18 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-09-28 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2025-04-23 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2017-09-22 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-05-03 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-02-12 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-05-15 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-25 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-23 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2026-01-13 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2021-04-30 |
| EJW | Clasp, Wire | Dental | Class 1 | 872.3285 | 2018-05-23 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2017-04-05 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2024-07-22 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-02-23 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-04-17 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-01-21 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-02-22 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2021-02-09 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2017-04-05 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2024-04-15 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-09-05 |
| DZB | Headgear, Extraoral, Orthodontic | Dental | Class 2 | 872.5500 | 2018-05-08 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | Class 3 | 878.4490 | 2017-09-28 |
| MDB | System, Blood Culturing | Microbiology | Class 1 | 866.2560 | 2024-08-23 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-03-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-01-28 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2018-05-08 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2019-02-11 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2018-03-22 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2018-03-22 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-01-24 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-09-22 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2018-05-08 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2016-09-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-19 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2017-02-23 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-09-18 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2022-03-31 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2019-02-08 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2019-01-24 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2017-09-22 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2023-11-20 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.1025 | 2024-07-24 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2024-07-24 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2017-09-28 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-05-08 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2024-02-06 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2017-02-27 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2023-03-30 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2022-07-22 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2021-04-28 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-09-05 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-04-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-09-07 |
| EXG | Bag, Urine Collecting, Ureterostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-08-08 |
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2017-09-28 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2020-09-17 |
| KNP | Orthosis, Corrective Shoe | Physical Medicine | Class 1 | 890.3475 | 2017-07-07 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-24 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-24 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2021-04-29 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-02-23 |
| HLS | Exophthalmometer | Ophthalmic | Class 1 | 886.1270 | 2024-12-13 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2017-02-23 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2017-02-23 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2017-02-27 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-11-22 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2016-09-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-12-02 |
| KMJ | Lubricant, Patient | General Hospital | Class 1 | 880.6375 | 2025-02-04 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2021-11-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-09-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-02-22 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2018-05-29 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2024-07-24 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2020-03-19 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2017-10-25 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2025-09-05 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2024-07-15 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-10-24 |
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4760 | 2026-03-13 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-24 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-08-22 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2024-04-02 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-07-07 |
| GAN | Suture, Absorbable, Synthetic | General, Plastic Surgery | Class 2 | 878.4830 | 2018-04-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-01-24 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-04-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-02-08 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2018-04-27 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-17 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2017-10-24 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2018-04-27 |
| LZG | Pump, Infusion, Insulin | General Hospital | Class 2 | 880.5725 | 2018-04-27 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2018-04-27 |
| NDC | Calculator, Drug Dose | Anesthesiology | Class 2 | 868.1890 | 2018-04-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-02-23 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2016-09-02 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2026-03-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-22 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2017-02-22 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2019-01-24 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2024-11-14 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2021-08-03 |
| NGT | Saline, Vascular Access Flush | General Hospital | Class 2 | 880.5200 | 2021-11-22 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2023-04-11 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2025-04-23 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-09-17 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-04-05 |
| DZD | Tube, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-04-08 |
| GXQ | Dura Substitute | Neurology | Class 2 | 882.5910 | 2020-01-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-09-08 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2021-08-27 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-02-28 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-04-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-08 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2019-01-24 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2020-03-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2023-12-14 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2022-04-13 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2021-03-25 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2020-09-03 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2020-09-03 |
| DZB | Headgear, Extraoral, Orthodontic | Dental | Class 2 | 872.5500 | 2018-05-08 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2022-04-28 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2022-04-28 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2022-04-28 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2025-05-09 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2017-11-08 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2021-05-19 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2017-09-28 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-09-28 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2024-07-15 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2017-09-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-02-23 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-11-14 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2017-09-28 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2025-01-29 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2023-05-24 |
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | Class 1 | 864.9125 | 2022-02-16 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2016-09-19 |
| DYW | Bracket, Plastic, Orthodontic | Dental | Class 2 | 872.5470 | 2019-10-18 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2025-09-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-13 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Neurology | Class 2 | 882.4305 | 2020-01-06 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2026-04-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-09-28 |
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | Class 1 | 878.4730 | 2021-03-29 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2023-06-20 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2017-09-22 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2025-01-17 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2018-05-08 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-11-14 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2026-01-28 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2024-10-21 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2026-04-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-08-22 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2017-02-23 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2017-09-22 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-02-08 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2018-05-08 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-05-20 |
| OIZ | Foot Examination Tool For Inflammatory Changes | Physical Medicine | Class 1 | 890.5050 | 2019-09-11 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-10-25 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-09-28 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2026-05-07 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2017-04-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-09-11 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-04-23 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2020-12-16 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2020-03-11 |
| ECI | Band, Elastic, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-09-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-06-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-25 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-03-20 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2018-03-26 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2022-06-01 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2021-04-28 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-08 |
| FXG | Specula Accessories | General, Plastic Surgery | Class 1 | 878.1800 | 2017-03-14 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-10-24 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2024-12-04 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2018-04-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-08 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-09-22 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-08 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2023-11-20 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-02-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-04-05 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2018-04-27 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2017-10-25 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2022-08-17 |
| MGP | Dressing, Wound And Burn, Occlusive | Unknown | Class U | N/A | 2016-09-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-10-25 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-09-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-02-08 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2016-09-20 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2016-09-19 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2024-12-12 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-04-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-09 |
| PNP | Dental Abutment Design Software For Dental Laboratory | Dental | Class 2 | 872.3630 | 2026-06-04 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2026-06-04 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2017-07-07 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | Dental | Class 2 | 872.3275 | 2024-07-15 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2024-07-15 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2018-04-27 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2017-07-07 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-02-23 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2019-06-25 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-09-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-09-28 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-10-24 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2026-06-03 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2024-04-15 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2024-04-15 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-16 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-01-24 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2024-10-11 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2024-10-11 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-09-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-13 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2022-01-26 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2022-01-26 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2021-05-18 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2020-01-13 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-04-08 |
| EKS | File, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-11-13 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2022-05-20 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2021-05-19 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2018-08-28 |
| EFH | Paper, Articulation | Dental | Class 1 | 872.6140 | 2017-02-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-08-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-09-28 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2017-09-28 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2017-09-28 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2017-02-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-02-13 |
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | Class 1 | 880.6350 | 2017-03-20 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-10-30 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-09-23 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-03-20 |
| PME | External Cleaning Solution | Dental | Class 2 | 872.3260 | 2020-10-23 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2020-10-23 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2019-01-24 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-01-20 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-07-27 |
| MDB | System, Blood Culturing | Microbiology | Class 1 | 866.2560 | 2024-08-23 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2025-09-05 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2016-09-19 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-22 |
| KIA | Cover, Cast | General Hospital | Class 1 | 880.6185 | 2024-03-18 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-05-07 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-05-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-05-07 |
| ECO | Spring, Orthodontic | Dental | Class 1 | 872.5410 | 2018-05-08 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2016-09-08 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2017-10-24 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-01-29 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2026-04-08 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2018-04-27 |
| KNM | Device, Pressure Applying | Physical Medicine | Class 1 | 890.5765 | 2017-03-20 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-04-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-04-08 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-10-24 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-09-19 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | Class 1 | 880.6150 | 2024-03-18 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2017-04-05 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2023-06-20 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-22 |
| LFC | Device, Caries Detection | Dental | Class 2 | 872.1740 | 2023-03-01 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2018-05-24 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2017-10-24 |
| EKP | Reamer, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2017-03-14 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2017-07-07 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2017-07-07 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2017-02-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-05-06 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2024-12-09 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-08-28 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2024-05-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2024-10-21 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-02-20 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-09-28 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2016-09-08 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2025-07-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-05-08 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2017-02-23 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-03-25 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2017-10-25 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2024-10-21 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-02-23 |
| IPR | Crutch | Physical Medicine | Class 1 | 890.3150 | 2021-11-09 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2018-05-15 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2026-01-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2024-03-20 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K020499 | Jeneric/Pentron, Inc. | BOND-3 ADHESIVE | 2002-04-22 |
| K801093 | Dentsply Intl. | PRISMA-BOND | 1980-05-20 |
| K061981 | Apex Dental Materials, Inc. | SURPASS | 2006-07-31 |
| K110302 | 3M Espe AG | ADHESIVE EXL-759 | 2011-05-19 |
| K071131 | 3M Espe AG Dental Products | UNO | 2007-07-25 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0035-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. |
| Z-0036-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222. |
| Z-0028-2020 | Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany | 2 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.). |
| Z-0030-2014 | Perkin Elmer Health Sciences, Inc. | 2 | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900.
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information. |
| Z-0011-2022 | Welch Allyn Inc Mortara | 2 | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:
ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX,
ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX,
ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX,
MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX,
ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX,
ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX,
ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD,
ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF,
MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX,
ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX,
ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX,
ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG,
ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG,
ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX,
ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX,
ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD,
ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD,
MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX,
MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG,
ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD,
ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX,
ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX,
ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX,
ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX,
ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD,
ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX,
ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD,
ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX,
ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX,
ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX,
ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD,
ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D,
ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027584973 | F & A LABORATORIO FARMACEUTICO LTDA | Sao Paulo-SP, BR |
| 3043226252 | ZAPALIGN LLC | Fort Lauderdale, FL, US |
| 2183301 | PATTERSON DENTAL SUPPLY, INC. | ST. PAUL, MN, US |
| 3038718579 | OKETZ LOGISTICS LLC | Coral Gables, FL, US |
| 9681254 | META BIOMED CO., LTD. | Cheongju-si Chungbuk, KR |
3012421607 when referencing this establishment in official correspondence.