510(k) K222992 ยท KIF Resin, Root Canal Filling
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
| Applicant | Innovative Bioceramix, Inc., Burnaby, CA |
| Decision | Substantially Equivalent, Nov 22, 2022 |
| Received | Sep 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222992
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.