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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 K221673
Device Name Bonafix TiBase
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 Juan Tezak
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/09/2022
Decision Date 07/14/2023
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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