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 |