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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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