Innovative Bioceramix, Inc. · Class II · Cleared Nov 22, 2022
| K-number | K222992 |
| Device name | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material |
| Applicant | Innovative Bioceramix, Inc. |
| Product code | KIF |
| Device class | Class II |
| Decision date | Nov 22, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 872.3820 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov