PME — External Cleaning Solution Class II
FDA product code PME covers "External Cleaning Solution", a Class II medical device regulated under 21 CFR 872.3260. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PME
- Device Class
- Class II
- Regulation Number
- 872.3260
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.