The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Self Cure Temporary Crown And Bridge Material.
| Device ID | K110484 |
| 510k Number | K110484 |
| Device Name: | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 |
| Contact | Cora Bracho-troconis |
| Correspondent | Cora Bracho-troconis NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2011-05-17 |