EKB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Explorer, Operative
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2003: 2 · 2004: 5
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 |
|---|---|---|
| 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS (K851724) | Artiberia | 1985-07-02 |
| EXPLORER TIP (K823914) | Treace Medical, Inc. | 1983-01-21 |
| BEACH EXPLORER NO. 23T.G. (K821780) | Pacific Dental Corp. | 1982-07-06 |
Track EKB automatically
Every clearance here is in the API, with alerts when new ones post.