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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 K153111
Device Name TOUAREG CloseFit™ UNP 2.75mmD
Applicant
Adin Dental Implants Systems Ltd.
Alon Tavor Industrial Zone, P.O. Box 1128
Afula,  IL 1811101
Applicant Contact Ilana Lutvak
Correspondent
QRS
Industrial Park Tefen
Tefen,  IL 2495900
Correspondent Contact Iman Khorshid
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/28/2015
Decision Date 05/06/2016
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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