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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K251196
Device Name Composite Orthodontic Brackets and Buttons
Applicant
EC Certification Service GmbH
Sandgasse 39a
Sankt Veit an der Glan,  AT 9300
Applicant Contact Elisabeth Moschik
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
DYW  
Date Received04/17/2025
Decision Date 04/21/2025
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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