SONIBRUSH
Device Facts
| Record ID | K935149 |
|---|---|
| Device Name | SONIBRUSH |
| Applicant | American Dentronics, Inc. |
| Product Code | JEQ · Dental |
| Decision Date | Jan 31, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6865 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement 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.