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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K202792
Device Name BRIUS Clear Aligners
Applicant
Brius Technologies, Inc
2611 Westgrove Dr Ste 109
Carrollton,  TX  75006
Applicant Contact Kate Garrett
Correspondent
Medavice, Inc.
11218 Zest Ct. NE
Blaine,  MN  55449
Correspondent Contact Jennifer Day
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/22/2020
Decision Date 01/22/2021
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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