QMJ — Powered Radiofrequency Toothbrush Class II
FDA product code QMJ covers "Powered Radiofrequency Toothbrush", a Class II medical device regulated under 21 CFR 872.6866. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QMJ
- Device Class
- Class II
- Regulation Number
- 872.6866
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.