POWERED TOOTHBRUSH
Device Facts
| Record ID | K970381 |
|---|---|
| Device Name | POWERED TOOTHBRUSH |
| Applicant | Emjoi Action USA, Ltd. |
| Product Code | JEQ · Dental |
| Decision Date | Apr 18, 1997 |
| 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.
