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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 K261357
Device Name Grandio disc multicolor
Applicant
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact Katrin Froehlich
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/24/2026
Decision Date 04/27/2026
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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