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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 K163385
Device Name Cortex Dental Implant System
Applicant
Cortex Dental Implants Industries , Ltd.
Shlomi Industrial Estate
Shlomi,  IL 22832
Applicant Contact Michal Yeger
Correspondent
Licensale, Inc.
68 Southwoods Ter.
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/02/2016
Decision Date 08/29/2017
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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