K231259 is an FDA 510(k) clearance for the iRoot SP Plus. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Innovative Bioceramix, Inc. (Burnaby, CA). The FDA issued a Cleared decision on May 31, 2023, 30 days after receiving the submission on May 1, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K231259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2023 |
| Decision Date | May 31, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |