The following data is part of a premarket notification filed by Septodont with the FDA for Bioroot Flow 0.5g, Bioroot Flow 2g.
| Device ID | K212283 |
| 510k Number | K212283 |
| Device Name: | BioRoot Flow 0.5g, BioRoot Flow 2g |
| Classification | Resin, Root Canal Filling |
| Applicant | Septodont 58, Rue Du Pont De Creteil Saint-maur Des Fosses Cedex, FR 94107 |
| Contact | Kimty Bui Van |
| Correspondent | Greg Montgomery Septodont 205 Granite Run Drive, Suite 150 Lancaster, PA 17601 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2021-09-16 |