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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 K161743
Device Name Etgar Dental Implant System
Applicant
Etgar Medical Instruments, Ltd.
North Industrial Area
Nahariyah,  IL 22102
Applicant Contact Yehudit Pe’er
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact Raymond Kelly
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/24/2016
Decision Date 04/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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