EMR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- File, Periodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2002: 5 · 2003: 53 · 2004: 17 · 2005: 19 · 2006: 9
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 |
|---|---|---|
| CIMPAT (K830109) | North Pacific Dental, Inc. | 1983-03-01 |
Track EMR automatically
Every clearance here is in the API, with alerts when new ones post.