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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 K182455
Device Name A.B. DENTAL DEVICES Dental Implants System
A.B. Dental Device Ltd.
19 Hayalomim Street
Ashdod,  IL 7761117
Applicant Contact Gabi Krauss
Hogan Lovells US LLP
555 13th Street
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number872.3630
Classification Product Code
Date Received09/07/2018
Decision Date 07/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No