The following data is part of a premarket notification filed by Novocol Inc. Dba Septodont And Confi-dental Produc with the FDA for Bpa-free Pit And Fissure Sealant.
| Device ID | K110058 |
| 510k Number | K110058 |
| Device Name: | BPA-FREE PIT AND FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC 416 S. TAYLOR AVE Louisville, CO 80027 |
| Contact | Cora Bracho-troconis |
| Correspondent | Cora Bracho-troconis NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC 416 S. TAYLOR AVE Louisville, CO 80027 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-03-31 |