The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Cimpat S Temporary Dental Cement.
| Device ID | K885007 |
| 510k Number | K885007 |
| Device Name: | CIMPAT S TEMPORARY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | S Reichertz |
| Correspondent | S Reichertz SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-01 |
| Decision Date | 1989-03-01 |