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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K233596
Device Name VarseoSmile TriniQ
Applicant
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Straße 1
Bremen,  DE 28359
Applicant Contact Marcel Müller
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBG   PZY  
Date Received11/08/2023
Decision Date 11/09/2023
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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