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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 K090709
Device Name CORTEX DENTAL IMPLANT SYSTEM
Applicant
Cortex Dental Implants Industries , Ltd.
Industrial Park 13
Mizpe Aviv, M.P. Misgav,  IL 20187
Applicant Contact BENNY AZARY
Correspondent
Cortex Dental Implants Industries , Ltd.
Industrial Park 13
Mizpe Aviv, M.P. Misgav,  IL 20187
Correspondent Contact BENNY AZARY
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/18/2009
Decision Date 07/07/2009
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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