PROPHYLAXIS CUP.
Device Facts
| Record ID | K803155 |
|---|---|
| Device Name | PROPHYLAXIS CUP. |
| Applicant | Teledyne Densco |
| Product Code | EHK · Dental |
| Decision Date | Jan 8, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6290 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.
