The following data is part of a premarket notification filed by Mechanodontics, Inc. with the FDA for Bruis Software Suite.
| Device ID | K191720 |
| 510k Number | K191720 |
| Device Name: | BRUIS Software Suite |
| Classification | Orthodontic Software |
| Applicant | Mechanodontics, Inc. 11110 Ohio Avenue Ste 206 Los Angeles, CA 90025 |
| Contact | Mehdi Roein-peikar |
| Correspondent | Breanne Butler RCQ Solutions 1321 Upland Suite 6792 Dr. Houston, TX 77043 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-27 |
| Decision Date | 2020-04-17 |