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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K181580
Device Name Cortex CAD/CAM Abutments
Applicant
Cortex Dental Implants Industries , Ltd.
Shlomi Industrial Estate
Shlomi,  IL 22832
Applicant Contact Ronit Polack
Correspondent
Licensale, Inc.
68 Southwoods Ter.
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/15/2018
Decision Date 01/29/2019
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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