K082943 is an FDA 510(k) clearance for the IROOT BP, MODEL IRBP 4609. 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 January 6, 2009, 96 days after receiving the submission on October 2, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K082943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2008 |
| Decision Date | January 06, 2009 |
| Days to Decision | 96 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 |