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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 K202092
Device Name ABC Dental Implant System
Applicant
Abracadabra Implants , Ltd.
12 Hacharoshet St.
Or Yehuda,  IL 6037580
Applicant Contact Daniel Younisian
Correspondent
Blackwell Device Consulating
12 Haharoshet St.
IL 6037580
Correspondent Contact Vladislav Dvoyris
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/28/2020
Decision Date 09/23/2021
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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