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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthodontic software
510(k) Number K191720
Device Name BRUIS Software Suite
Applicant
Mechanodontics, Inc.
11110 Ohio Avenue Ste 206
Los Angeles,  CA  90025
Applicant Contact Mehdi Roein-Peikar
Correspondent
RCQ Solutions
1321 Upland Suite 6792 Dr.
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number872.5470
Classification Product Code
PNN  
Date Received06/27/2019
Decision Date 04/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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