Handle, Instrument, Dental
Regulation 872.4565
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Aukland Medical Plastics, Inc. | 1 | 0 |
| Biomet 3i, Inc. | 0 | 1 |
| Centrix, Inc. | 1 | 0 |
| E&D Dental Products, Inc. | 1 | 0 |
| Joel Lander D.D.S. | 1 | 0 |
| Lone Star Technologies | 1 | 0 |
| Military Engineering, Inc. | 1 | 0 |
| Neks Technologies | 1 | 0 |
| Treace Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2014 | K140144 | BENDA WEDGE Centrix, Inc. | EJB |
| Jun 25, 2003 | K023367 | DETECTAR, MODEL N123-MI Neks Technologies | EJB |
| Jun 5, 1998 | K981234 | FLARE,FILE, FILL Lone Star Technologies | EJB |
| Oct 20, 1993 | K930094 | AUKUSLEEVE Aukland Medical Plastics, Inc. | EJB |
| Aug 6, 1992 | K922633 | CAVI-ZYME E&D Dental Products, Inc. | EJB |
| Jul 2, 1987 | K871818 | SPATULA, DENTAL, CEMENT Military Engineering, Inc. | EJB |
| Nov 25, 1983 | K833338 | TOOTH SLOOTH Joel Lander D.D.S. | EJB |
| Jan 26, 1983 | K823913 | SOFT GRIP UNI-HANDLE Treace Medical, Inc. | EJB |
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