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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 K251239
Device Name GrandioSO Unlimited
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 Number872.3690
Classification Product Code
EBF  
Date Received04/22/2025
Decision Date 05/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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