The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Bpa-free Microhybid Composite.
| Device ID | K120237 |
| 510k Number | K120237 |
| Device Name: | BPA-FREE MICROHYBID COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | NOVOCOL, INC. 416 S Taylor Ave Louisville, CO 80027 |
| Contact | Cora Bracho-troconis |
| Correspondent | Cora Bracho-troconis NOVOCOL, INC. 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 | 2012-01-26 |
| Decision Date | 2012-12-11 |