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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 Ave. Suite 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
Predetermined Change
Control Plan Authorized		 No
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