BRUIS Software Suite

Orthodontic Software

Mechanodontics, Inc.

The following data is part of a premarket notification filed by Mechanodontics, Inc. with the FDA for Bruis Software Suite.

Pre-market Notification Details

Device IDK191720
510k NumberK191720
Device Name:BRUIS Software Suite
ClassificationOrthodontic Software
Applicant Mechanodontics, Inc. 11110 Ohio Avenue Ste 206 Los Angeles,  CA  90025
ContactMehdi Roein-peikar
CorrespondentBreanne Butler
RCQ Solutions 1321 Upland Suite 6792 Dr. Houston,  TX  77043
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-27
Decision Date2020-04-17

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