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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K262681
Device Name NanoCeram Resin
Applicant
3BFAB TEKNOLOJI A.S.
Dudullu Osb Mah. Imes Sk. E-Blok No:9
Istanbul,  TR 34775
Applicant Contact Ömer Arslan
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact DAVE YUNGVIRT
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBF   PZY  
Date Received07/30/2026
Decision Date 07/31/2026
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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