The following data is part of a premarket notification filed by Novocol Inc. Dba Septodont And Confi-dental Produc with the FDA for Granitec Dual-cure Core Build-up, N'durance Dimer Core.
| Device ID | K101540 |
| 510k Number | K101540 |
| Device Name: | GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC 416 S. TAYLOR AVE Louisville, CO 80027 |
| Contact | Steve Rudolph |
| Correspondent | Steve Rudolph NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC 416 S. TAYLOR AVE Louisville, CO 80027 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020718 | K101540 | 000 |