The following data is part of a premarket notification filed by Brius Technologies Inc with the FDA for Brius Planner Software.
| Device ID | K212828 |
| 510k Number | K212828 |
| Device Name: | BRIUS Planner Software |
| Classification | Orthodontic Software |
| Applicant | BRIUS Technologies Inc 2611 Westgrove Dr Carrollton, TX 75006 |
| Contact | Mehdi Roein-peiker |
| Correspondent | Breanne Butler Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2021-10-01 |