The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Oralchek Super-soft Brush.
| Device ID | K892264 |
| 510k Number | K892264 |
| Device Name: | ORALCHEK SUPER-SOFT BRUSH |
| Classification | Toothbrush, Manual |
| Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Contact | David C Oppenheimer |
| Correspondent | David C Oppenheimer PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-06-14 |