The following data is part of a premarket notification filed by Innovative Bioceramix Inc. with the FDA for Iroot Bp Root Repair Material Bioaggregate Paste;iroot Fs Fast Set Root Repair Material ;iroot Bp Plus Root Repair Material.
| Device ID | K222992 |
| 510k Number | K222992 |
| Device Name: | IRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material |
| Classification | Resin, Root Canal Filling |
| Applicant | Innovative BioCeramix Inc. 101-8218 North Fraser Way Burnaby, CA V3N0E9 |
| Contact | Quanzu Yang |
| Correspondent | Quanzu Yang Innovative BioCeramix, Inc. 101-8218 North Fraser Way Burnaby, CA V3N039 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-28 |
| Decision Date | 2022-11-22 |