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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 K250178
Device Name Adin Customized Abutments
Applicant
Adin Dental Implant Systems , Ltd.
Alon Tavor Industrial Zone P.O. B 1128
Afula,  IL 1811101
Applicant Contact Dimitry Beliavsky
Correspondent
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad,  CA  92008
Correspondent Contact Floyd Larson
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received01/22/2025
Decision Date 10/17/2025
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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