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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 K202144
Device Name A.B. Dental Devices Dental Implants System
Applicant
A.B. Dental Device Ltd.
19 Hayalomim Street
Ashdod,  IL 7761117
Applicant Contact Gabi Krauss
Correspondent
Nissim Shaked RA Specialist
17th Tel-Hay St.
Raanana,  IL 4340525
Correspondent Contact Nissim Shaked
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/31/2020
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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