The following data is part of a premarket notification filed by Septodont, Inc. with the FDA for Detartrine P.
| Device ID | K760658 |
| 510k Number | K760658 |
| Device Name: | DETARTRINE P |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | SEPTODONT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-15 |
| Decision Date | 1976-09-27 |