The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Cimpat S Dental Cement.
| Device ID | K915467 |
| 510k Number | K915467 |
| Device Name: | CIMPAT S DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020640 | K915467 | 000 |
| 00816519020633 | K915467 | 000 |