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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
BRIUS Technologies Inc
2611 Westgrove Dr
Carrollton,  TX  75006
Applicant Contact Mehdi Roein-Peiker
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number872.5470
Classification Product Code
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