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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K251294
Device Name Bonafix Implant Abutments
Applicant
Zentek Medical, LLC
200 Craig Rd.
Suite 107
Manalapan,  NJ  07726
Applicant Contact Michael Vinnik
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Carlos Marín
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/25/2025
Decision Date 10/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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