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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 K261840
Device Name BracePaste Prime Plus
Applicant
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Applicant Contact Laura Richmond
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact DAVE YUNGVIRT
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Code
KLE  
Date Received06/02/2026
Decision Date 06/03/2026
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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