EJB
8 FDA 510(k) clearances · Product code
78 daysmedian time to decision
285 days90th percentile
8clearances measured
FDA profile
- Official device name
- Handle, Instrument, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1997: 1 · 1999: 1 · 2010: 18 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BENDA WEDGE (K140144) | Centrix, Inc. | 2014-07-08 |
| DETECTAR, MODEL N123-MI (K023367) | Neks Technologies | 2003-06-25 |
| FLARE,FILE, FILL (K981234) | Lone Star Technologies | 1998-06-05 |
| AUKUSLEEVE (K930094) | Aukland Medical Plastics, Inc. | 1993-10-20 |
| CAVI-ZYME (K922633) | E&D Dental Products, Inc. | 1992-08-06 |
| SPATULA, DENTAL, CEMENT (K871818) | Military Engineering, Inc. | 1987-07-02 |
| TOOTH SLOOTH (K833338) | Joel Lander D.D.S. | 1983-11-25 |
| SOFT GRIP UNI-HANDLE (K823913) | Treace Medical, Inc. | 1983-01-26 |
Track EJB automatically
Every clearance here is in the API, with alerts when new ones post.