FDA Device Registration & Listing · Shaker Heights, OH, US · Registration 3010864832
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2017-06-12 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2014-04-28 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2019-01-24 |
| FYE | Dress, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2017-01-17 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2017-11-30 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2021-07-15 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2015-11-20 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2015-11-20 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2015-11-20 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2015-11-20 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2022-10-31 |
| NRU | Chair, Dental, Without Operative Unit | Dental | Class 1 | 872.6250 | 2022-10-31 |
| KHA | Mask, Scavenging | Anesthesiology | Class 1 | 868.5590 | 2019-01-24 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2015-01-30 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-06-16 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2018-09-21 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-09-10 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2022-10-31 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2023-01-19 |
| IWZ | Film, Radiographic | Radiology | Class 1 | 892.1840 | 2022-10-31 |
| EKK | Spreader, Pulp Canal Filling Material, Endodontic | Dental | Class 1 | 872.4565 | 2023-02-13 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2017-06-12 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-04-20 |
| ELM | Denture, Plastic, Teeth | Dental | Class 2 | 872.3590 | 2026-02-12 |
| EAT | Tester, Pulp | Dental | Class 2 | 872.1720 | 2016-11-24 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2026-03-12 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2016-07-13 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2016-07-05 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2019-09-10 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2014-05-12 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2020-09-08 |
| EKN | Point, Paper, Endodontic | Dental | Class 1 | 872.3830 | 2016-07-03 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-07-08 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2018-07-03 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2015-05-05 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2016-08-18 |
| NRD | Unit, Operative Dental, Accessories | Dental | Class 1 | 872.6640 | 2018-06-25 |
| EGD | Wax, Dental, Intraoral | Dental | Class 1 | 872.6890 | 2023-01-19 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2018-09-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-03-23 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2021-03-02 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2021-03-02 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2021-03-02 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2019-01-24 |
| OLR | Oral Wound Dressing | Unknown | Class U | N/A | 2018-02-16 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2016-07-05 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-08-08 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2019-01-24 |
| EFD | Amalgamator, Dental, Ac-Powered | Dental | Class 1 | 872.3100 | 2019-07-26 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2017-07-17 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-02-16 |
| KCQ | Tube Impression And Matrix | Dental | Class 1 | 872.6570 | 2017-01-24 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2017-09-25 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2019-11-13 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2016-07-13 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2026-02-16 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2022-10-31 |
| IWO | Apron, Protective | Radiology | Class 1 | 892.6500 | 2022-02-10 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2019-09-10 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-09-10 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2017-02-07 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2016-06-16 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-08-27 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2019-09-10 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-03-22 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2022-10-31 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2017-03-30 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-11-30 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2017-03-30 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2022-06-22 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2017-07-05 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2017-08-31 |
| EKS | File, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2017-01-23 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2016-09-15 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2026-02-12 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2019-02-08 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2019-02-08 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2020-09-21 |
| EKM | Gutta-Percha | Dental | Class 1 | 872.3850 | 2016-07-03 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2016-08-25 |
| LQY | Locator, Root Apex | Unknown | Class U | N/A | 2020-12-16 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2019-09-10 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2017-08-21 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-08-11 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2022-08-11 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K121698 | Dentsply International, Inc. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 2012-08-06 |
| K033295 | Novamin Technology, Inc. | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN | 2003-10-28 |
| K072322 | Smith & Nephew, Inc. | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | 2007-09-18 |
| K241486 | Covidien | Sofsilk Coated Braided Silk Suture | 2024-12-03 |
| K212910 | Shenzhen Carejoy Technology Co., Ltd. | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | 2022-11-17 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-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-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. |
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Z-0004-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003628967 | SUNG LIM INDUSTRIES, CO., LTD. | Bucheon-si Gyeonggi, KR |
| 3007616062 | IRIS BEAUTY SUPPLIES INC | DOLLARD-DES-ORMEAUX Quebec, CA |
| 3032760064 | CARAN PRECISION ENGINEERING & MANUFACTURING CORP. | Brea, CA, US |
| 3010615336 | PODOPRO UK LTD | HUDDERSFIELD England, GB |
| 3003902419 | DALIAN WENJING WOODEN INDUSTRY CO., LTD. | DALIAN Liaoning, CN |
3010864832 when referencing this establishment in official correspondence.