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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 K160221
Device Name Implance Dental Implant System, Implance Dental Abutment System
Applicant
Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.
Mahmut Yesari Caddesi No: 25
Istanbul,  TR 34718
Applicant Contact Gorkem Serce
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact H. Semih Oktay
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/29/2016
Decision Date 09/12/2016
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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