EKD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument, Cutting, Operative
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1998: 2 · 1999: 3 · 2002: 4 · 2005: 2 · 2010: 3
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 |
|---|---|---|
| 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (K851723) | Artiberia | 1985-07-02 |
| BEACH EXCAVATOR'S NO. 1 & NO. 2 (K821790) | Pacific Dental Corp. | 1982-07-06 |
Track EKD automatically
Every clearance here is in the API, with alerts when new ones post.