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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 K160782
Device Name BracePaste Adhesive
Applicant
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Applicant Contact Trang Adams
Correspondent
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Correspondent Contact Trang Adams
Regulation Number872.3750
Classification Product Code
DYH  
Date Received03/22/2016
Decision Date 10/14/2016
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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