The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Bioroot Rcs.
| Device ID | K130601 |
| 510k Number | K130601 |
| Device Name: | BIOROOT RCS |
| Classification | Resin, Root Canal Filling |
| 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 | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-10-17 |
| Summary: | summary |