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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 K163349
Device Name MIS V3 Conical Connection Dental Implant System­
Applicant
Mis Implants Technologies , Ltd.
P.O. Box 7 Bar Lev Industrial Park
Bar Lev Industrial Park,  IL 2015600
Applicant Contact Arbel Shezaf
Correspondent
Mis Implants Technologies , Ltd.
P.O. Box 7 Bar Lev Industrial Park
Bar Lev Industrial Park,  IL 2015600
Correspondent Contact Arbel Shezaf
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/29/2016
Decision Date 05/26/2017
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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