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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K252031
Device Name Adin Long Dental Implant System
Applicant
Adin Dental Implant Systems , Ltd.
Alon Tavor Industrial Zone P.O.Box 1128
Afula,  IL 1811101
Applicant Contact Beliavsky Dimitry
Correspondent
Adin Dental Implant Systems , Ltd.
325 Betty Ann Dr.
Toronto,  CA M2R 1B4
Correspondent Contact Tal Bresler-Stramer
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/30/2025
Decision Date 03/23/2026
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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