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 |