K130312 is an FDA 510(k) clearance for the IROOT FM. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Innovative Bioceramix, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on September 18, 2014, 588 days after receiving the submission on February 7, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K130312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2013 |
| Decision Date | September 18, 2014 |
| Days to Decision | 588 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |