SMYLON (DENTAL STAIN ERASER)
Device Facts
| Record ID | K891338 |
|---|---|
| Device Name | SMYLON (DENTAL STAIN ERASER) |
| Applicant | The Smylon Co. |
| Product Code | MAU · Dental |
| Decision Date | Nov 14, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6855 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.