FDA Device Registration & Listing · Coral Gables, FL, US · Registration 3038718579
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 |
|---|---|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-12-08 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-12-08 |
| MED | Sterilant, Medical Devices | General Hospital | Class 2 | 880.6885 | 2025-12-02 |
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | Class 1 | 878.4040 | 2025-12-08 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-26 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2026-02-04 |
| NRD | Unit, Operative Dental, Accessories | Dental | Class 1 | 872.6640 | 2025-12-09 |
| ELL | Teeth, Porcelain | Dental | Class 2 | 872.3920 | 2025-12-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-02 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2025-11-26 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-11-26 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-11-26 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-26 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2025-12-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2025-12-11 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-08 |
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2025-12-17 |
| EKQ | Preparer, Root Canal Endodontic | Dental | Class 1 | 872.4565 | 2025-12-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| EKM | Gutta-Percha | Dental | Class 1 | 872.3850 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-02 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2025-12-11 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-12-02 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-27 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2025-11-26 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-20 |
| EEG | Heat Source For Bleaching Teeth | Dental | Class 1 | 872.6475 | 2025-12-11 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2025-12-11 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| MED | Sterilant, Medical Devices | General Hospital | Class 2 | 880.6885 | 2025-11-26 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-03-11 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-03-11 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-04 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-02 |
| MED | Sterilant, Medical Devices | General Hospital | Class 2 | 880.6885 | 2025-12-02 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-11-27 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-03-11 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2025-12-09 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2025-12-04 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2025-12-04 |
| ELY | Mercury | Dental | Class 2 | 872.3070 | 2025-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-27 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-08 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-04 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-12-02 |
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | Class 1 | 880.6190 | 2025-12-11 |
| EJQ | Wheel, Polishing Agent | Dental | Class 1 | 872.6010 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-11-27 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| ODA | Endoscopic Central Control Unit | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-06-17 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2025-12-11 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2025-12-02 |
| KJJ | Cleanser, Root Canal | Unknown | Class U | N/A | 2025-12-02 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-11-27 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-02 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | Class 2 | 878.4370 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | Class 1 | 888.4210 | 2025-12-08 |
| MED | Sterilant, Medical Devices | General Hospital | Class 2 | 880.6885 | 2025-12-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-27 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2025-12-11 |
| FFR | Device, Locking, For Intestinal Clamp | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-12-08 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2025-12-11 |
| EAT | Tester, Pulp | Dental | Class 2 | 872.1720 | 2025-12-02 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2025-11-26 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-08 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2025-12-08 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-12-02 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2025-11-26 |
| EKP | Reamer, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-04 |
| EKS | File, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| KMY | Positioner, Tooth, Preformed | Dental | Class 1 | 872.5525 | 2026-03-26 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2025-12-08 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| ECQ | Aligner, Bracket, Orthodontic | Dental | Class 1 | 872.4565 | 2025-12-11 |
| BWP | Shoe And Shoe Cover, Conductive | General, Plastic Surgery | Class 1 | 878.4040 | 2025-12-11 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2025-12-04 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| ELL | Teeth, Porcelain | Dental | Class 2 | 872.3920 | 2025-12-02 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-26 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2025-12-08 |
| IWZ | Film, Radiographic | Radiology | Class 1 | 892.1840 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| KOJ | Airbrush | Dental | Class 2 | 872.6080 | 2025-12-04 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-08 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2025-12-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-11-27 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-11-26 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2025-11-27 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2025-11-27 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2025-12-09 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2025-12-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-27 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2025-11-26 |
| LFC | Device, Caries Detection | Dental | Class 2 | 872.1740 | 2025-12-04 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2026-02-04 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2025-12-08 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-20 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2025-11-27 |
| KCQ | Tube Impression And Matrix | Dental | Class 1 | 872.6570 | 2025-12-11 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2025-12-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-12-02 |
| HBA | Neurosurgical Paddie | Neurology | Class 2 | 882.4700 | 2025-11-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-04 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-27 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-09 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-26 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-11-27 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-11-27 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2025-12-11 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-11-27 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-27 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-12-02 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-27 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-11-27 |
| KJJ | Cleanser, Root Canal | Unknown | Class U | N/A | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-12-08 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-27 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-12-02 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2025-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EFH | Paper, Articulation | Dental | Class 1 | 872.6140 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2025-12-08 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2025-11-27 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2025-12-11 |
| BTC | Bag, Reservoir | Anesthesiology | Class 1 | 868.5320 | 2025-12-11 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | Dental | Class 2 | 872.4920 | 2025-11-26 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2025-11-26 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EHM | Strip, Polishing Agent | Dental | Class 1 | 872.6010 | 2025-12-08 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2025-12-11 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2025-11-27 |
| GCZ | Retainer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-04 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2025-12-08 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2025-12-08 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2025-12-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-11-27 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-11-27 |
| KMT | Tray, Fluoride, Disposable | Dental | Class 1 | 872.6870 | 2025-12-09 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2025-12-08 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2025-11-27 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2025-12-11 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-12-04 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2025-12-02 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2025-11-27 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-12-02 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2025-12-11 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2025-11-26 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-11-26 |
| LQY | Locator, Root Apex | Unknown | Class U | N/A | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-11-26 |
| DZI | Drill, Bone, Powered | Dental | Class 2 | 872.4120 | 2025-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-04 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-27 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2025-12-11 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| EFT | Cleanser, Denture, Over The Counter | Dental | Class 1 | 872.3520 | 2025-12-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-27 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2025-12-09 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2025-12-08 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2025-12-11 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2025-11-27 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2025-12-04 |
| EKK | Spreader, Pulp Canal Filling Material, Endodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2025-12-04 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-12-04 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2025-12-09 |
| KJJ | Cleanser, Root Canal | Unknown | Class U | N/A | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2025-12-02 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-12-04 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-27 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-27 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-03-11 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2025-12-04 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2025-11-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-08 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-11-27 |
| NRU | Chair, Dental, Without Operative Unit | Dental | Class 1 | 872.6250 | 2025-12-11 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2025-12-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2025-12-09 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2025-12-09 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EZR | Cement, Stomal Appliance, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2025-12-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-27 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-26 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2025-12-08 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-05-26 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2025-12-08 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2025-12-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2025-12-08 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2025-12-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-08 |
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | Class 2 | 878.4370 | 2025-11-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-17 |
| FLE | Sterilizer, Steam | General Hospital | Class 2 | 880.6880 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2025-12-08 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-02 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-08 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2026-05-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-27 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2025-11-27 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2025-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-08 |
| MAU | Eraser, Dental Stain | Dental | Class 1 | 872.6855 | 2025-12-08 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2025-12-08 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2025-11-26 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-12-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-02 |
| LFC | Device, Caries Detection | Dental | Class 2 | 872.1740 | 2025-11-26 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2025-12-04 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2025-12-08 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2025-12-04 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-12-04 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-20 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2025-11-26 |
| EHL | Point, Abrasive | Dental | Class 1 | 872.6010 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-02 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-11 |
| EKL | Point, Silver, Endodontic | Dental | Class 1 | 872.3840 | 2025-12-04 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2025-12-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-02 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-11-26 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2025-12-11 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2025-12-08 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2025-12-08 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-12-04 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-12-08 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-12-02 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2025-12-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2025-12-08 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2025-12-09 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-27 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2025-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2025-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-26 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2025-11-26 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2025-12-09 |
| LDS | Device, Pasteurization, Hot Water | General Hospital | Class 2 | 880.6991 | 2025-12-11 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2025-12-02 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2025-12-04 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-11-26 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2025-12-11 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2025-12-08 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-11-27 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2025-12-08 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2025-12-08 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2025-12-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-11-26 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2025-11-27 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2025-12-08 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2025-06-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-12-04 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-11-26 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2025-12-02 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K952662 | Jeneric/Pentron, Inc. | COMP=FLOW | 1995-08-28 |
| K171147 | Bisco, Inc. | REVEAL Bulk | 2017-08-04 |
| K770922 | Espe GmbH (Us) | DENTAL RESTORATIVE IN CAPSULES | 1977-06-01 |
| K153476 | Kuraray Noritake Dental, Inc. | KATANA AVENCIA Block | 2016-08-23 |
| K800400 | Dentsply Intl. | MAXUM DENTURE RESIN | 1980-03-12 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-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-0034-2009 | Surgical Specialties Corp | 2 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures. |
| Z-0027-2007 | N/A | 2 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3015259866 | SWIK Medical Solutions | Farmington Hills, MI, US |
| 3013584824 | ERGOMEDI LTD. | Espoo Uusimaa, FI |
| 3015703934 | MEDFRUITION ELECTRONICS TECHNOLOGY CO., LTD | Foshan City Guangdong, CN |
| 3010162973 | Synergy Health Marseille SAS | MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR |
| 3015146495 | MOLDED DEVICES, INC. | Tempe, AZ, US |
3038718579 when referencing this establishment in official correspondence.