PFL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intraoral, Dental Foam Protector
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6890
- Medical specialty
- Dental
- FDA definition
- Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WIRED MOUTH PROTECTOR (WMP) (K131396) | Elba Laboratories, Inc. | 2013-09-30 |
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