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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 K250806
Device Name Dental Implant System
Applicant
A.B. Dental Devices , Ltd.
Hayahalomim 19
Ashdod,  IL 7761117
Applicant Contact Victoria Zabit
Correspondent
A.B. Dental Devices , Ltd.
Hayahalomim 19
Ashdod,  IL 7761117
Correspondent Contact Victoria Zabit
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/17/2025
Decision Date 06/18/2026
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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