The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Py-co-prox Tm Dental Brush.
| Device ID | K800831 |
| 510k Number | K800831 |
| Device Name: | PY-CO-PROX TM DENTAL BRUSH |
| Classification | Toothbrush, Manual |
| Applicant | BLOCK DRUG COMPANY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-14 |
| Decision Date | 1980-05-08 |