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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K181910
Device Name BracePaste MTP Light Cure Primer
Applicant
American Orthodontics
3524 Washington Avenue
Sheboygan,  WI  53081
Applicant Contact Trang Adams
Correspondent
American Orthodontics
3524 Washington Avenue
Sheboygan,  WI  53081
Correspondent Contact Andre Leak
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/17/2018
Decision Date 10/15/2018
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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