The following data is part of a premarket notification filed by Innovative Bioceramix Inc. with the FDA for Iroot Fm.
| Device ID | K130312 |
| 510k Number | K130312 |
| Device Name: | IROOT FM |
| Classification | Resin, Root Canal Filling |
| Applicant | INNOVATIVE BIOCERAMIX INC. 1628 WEST 75TH AVE. Vancouver, Bc, CA V6p 6g2 |
| Contact | Quanzu Yang |
| Correspondent | Quanzu Yang INNOVATIVE BIOCERAMIX INC. 1628 WEST 75TH AVE. Vancouver, Bc, CA V6p 6g2 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2014-09-18 |
| Summary: | summary |