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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 K253236
Device Name G-BLOCK
Applicant
Graphenano Dental S.L.
Polígono Industrial Táctica C/2a Nº1
Valencia,  ES 46980
Applicant Contact Eva Navarro
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/29/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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