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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K202276
Device Name BracePaste Band and Build LC
Applicant
American Orthodontics
3524 Washington Avenue
Sheboygan,  WI  53081
Applicant Contact Andre Leak
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number872.3750
Classification Product Code
DYH  
Date Received08/11/2020
Decision Date 08/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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