FDA Device Registration & Listing · Lake Saint Louis, MO, US · Registration 1937100
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2019-03-13 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2023-06-29 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2018-09-06 |
| EEJ | Guard, Disk | Dental | Class 1 | 872.6010 | 2018-02-08 |
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| DYT | Maintainer, Space Preformed, Orthodontic | Dental | Class 1 | 872.5525 | 2011-09-02 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2017-08-25 |
| ECT | Driver, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2011-09-02 |
| ECQ | Aligner, Bracket, Orthodontic | Dental | Class 1 | 872.4565 | 2011-09-02 |
| EAT | Tester, Pulp | Dental | Class 2 | 872.1720 | 2017-10-12 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2014-04-23 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-04-16 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2018-01-22 |
| EGD | Wax, Dental, Intraoral | Dental | Class 1 | 872.6890 | 2011-09-02 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2016-06-14 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2012-01-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-02-05 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2012-01-19 |
| EHM | Strip, Polishing Agent | Dental | Class 1 | 872.6010 | 2016-11-11 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2014-09-12 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2018-10-15 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 2016-11-11 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2023-06-29 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-13 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2017-05-17 |
| ECR | Setter, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2011-09-02 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2023-06-29 |
| KMY | Positioner, Tooth, Preformed | Dental | Class 1 | 872.5525 | 2017-08-25 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2021-08-16 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2023-06-09 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-09-07 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2013-07-29 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2014-04-23 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2016-06-14 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Dental | Class 2 | 872.3661 | 2013-07-02 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-04-24 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2023-11-20 |
| ECO | Spring, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2019-03-13 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2012-06-29 |
| DZD | Tube, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| ECM | Band, Preformed, Orthodontic | Dental | Class 1 | 872.5410 | 2011-09-02 |
| LQZ | Device, Jaw Repositioning | Dental | Class 2 | 872.5570 | 2023-11-20 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2023-11-20 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2011-09-02 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2011-09-02 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2014-04-03 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2017-08-04 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K112640 | Ormco Corp. | HYPERELASTIC WIRE | 2011-11-16 |
| K122391 | Medtronic Xomed, Inc. | MEDTRONIC XOMED, INC. | 2013-01-10 |
| K180404 | 3M Healthcare | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 2018-03-16 |
| K121698 | Dentsply International, Inc. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 2012-08-06 |
| K882164 | Arthur Blank & Co., Inc. | FLOSS CARD | 1988-06-10 |
| 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.). |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1000379569 | Wire and Cable Specialties, Inc. | Coatesville, PA, US |
| 3038252913 | ADVANCED ORTHODONTIC SOLUTIONS | Tampa, FL, US |
| 3027343382 | UNIVY TECHNOLOGY ADVANCED CO. LTD | Shanghai, CN |
| 3009827000 | WHITE OAK ORTHODONTIC PRODUCTS | Mount Joy, PA, US |
| 3038718579 | OKETZ LOGISTICS LLC | Coral Gables, FL, US |
1937100 when referencing this establishment in official correspondence.