The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sternomega Compomer Cement.
| Device ID | K982895 |
| 510k Number | K982895 |
| Device Name: | STERNOMEGA COMPOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket, RI 02860 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket, RI 02860 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2120351 | K982895 | 000 |