The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Bulk Fill Flowable Composite.
| Device ID | K141994 |
| 510k Number | K141994 |
| Device Name: | BULK FILL FLOWABLE COMPOSITE |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-22 |
| Decision Date | 2014-11-14 |
| Summary: | summary |