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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K252073
Device Name VOCO Profluorid Varnish + BioMin
Applicant
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact Katrin Froehlich
Correspondent
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Correspondent Contact Katrin Froehlich
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/02/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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