PFL — Intraoral, Dental Foam Protector Class I
FDA product code PFL covers "Intraoral, Dental Foam Protector", a Class I medical device regulated under 21 CFR 872.6890. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFL
- Device Class
- Class I
- Regulation Number
- 872.6890
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131396 | elba laboratories | WIRED MOUTH PROTECTOR (WMP) | September 30, 2013 |