FDA Device Registration & Listing · Richmond Hill Ontario, CA · Registration 3003120666
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-17 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2024-05-10 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-17 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2019-12-17 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-03-18 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-06-18 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2023-09-28 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2025-11-21 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-06-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-06-10 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2024-12-19 |
| ELM | Denture, Plastic, Teeth | Dental | Class 2 | 872.3590 | 2024-12-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2023-09-28 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2025-05-30 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2025-05-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2025-11-21 |
| EHL | Point, Abrasive | Dental | Class 1 | 872.6010 | 2024-10-23 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-03-29 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-03-29 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2025-11-21 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2026-04-12 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2026-02-10 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-11-28 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-11-21 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2025-11-21 |
| EHM | Strip, Polishing Agent | Dental | Class 1 | 872.6010 | 2024-12-19 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-05-05 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-05-05 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-05-05 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2024-12-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-05-19 |
| ELM | Denture, Plastic, Teeth | Dental | Class 2 | 872.3590 | 2024-12-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-04-12 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2025-11-21 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2024-12-19 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2025-11-21 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2025-05-19 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2026-03-29 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2026-03-29 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2026-03-29 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2024-12-12 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2024-12-19 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2026-05-05 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2024-12-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2024-12-19 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2024-12-19 |
| EFH | Paper, Articulation | Dental | Class 1 | 872.6140 | 2024-12-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2019-12-17 |
| EHK | Cup, Prophylaxis | Dental | Class 1 | 872.6290 | 2024-12-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2026-03-29 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2026-04-12 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2025-11-21 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2024-12-09 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2024-12-19 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-05-05 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2025-11-21 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K212801 | Hong Seng Gloves Sdn Bhd | Powder free nitrile examination glove- black, non sterile | 2022-01-09 |
| K260806 | Vista Industries,, LLC | Nitrile Disposable Examination Gloves | 2026-06-03 |
| K011593 | Ansell Healthcare Products, Inc. | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | 2001-06-21 |
| K981039 | Sri Johani Sdn. Bhd. | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | 1998-04-21 |
| K101595 | Better Care Plastic Technology Cp., Ltd. | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | 2010-08-06 |
| 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-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 |
| Z-0005-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3030671502 | GUANGDONG VYIMED CO., LTD. | Qingyuan Guangdong, CN |
| 9610406 | ANSELL (THAILAND) LTD. | THAILAND Krung Thep Maha Nakhon, TH |
| 3026062711 | RMKH GLOVE (CAMBODIA) CO., LTD. | Bavet City Svay Rieng, KH |
| 3043739177 | US Paper Mill LLC | Chillicothe, OH, US |
| 3042765418 | VITAL EDGE INSTRUMENTS LLC | Leesburg, VA, US |
3003120666 when referencing this establishment in official correspondence.