BRW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Protector, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5820
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1994: 1 · 2002: 2 · 2005: 2
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 |
|---|---|---|
| CATCO NEONATAL PALATE GUARD (K945727) | Catco Medical, Inc. | 1994-12-07 |
| WILEY/ESPOSITO DENTAL GUARD (K935713) | Fvtnks | 1994-01-05 |
| TIP TOLEDO INCISOR PROTECTOR (K851640) | Edward O. Goodwich | 1985-09-18 |
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Every clearance here is in the API, with alerts when new ones post.