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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 K212828
Device Name BRIUS Planner Software
Applicant
BRIUS Technologies Inc
2611 Westgrove Dr
Carrollton,  TX  75006
Applicant Contact Mehdi Roein-Peiker
Correspondent
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number872.5470
Classification Product Code
PNN  
Date Received09/03/2021
Decision Date 10/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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