The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Dimer Dual Cure Permanent/temporary Resin Cement.
| Device ID | K120283 |
| 510k Number | K120283 |
| Device Name: | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT |
| Classification | Cement, Dental |
| Applicant | NOVOCOL, INC. 416 S Taylor Ave Louisville, CO 80027 |
| Contact | Cora Bracho-trosonis |
| Correspondent | Cora Bracho-trosonis NOVOCOL, INC. 416 S Taylor Ave Louisville, CO 80027 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-31 |
| Decision Date | 2012-07-31 |