K222992 is an FDA 510(k) clearance for the iRoot BP Root Repair Material BioAggregate Paste. 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 November 22, 2022, 55 days after receiving the submission on September 28, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K222992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2022 |
| Decision Date | November 22, 2022 |
| Days to Decision | 55 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 |