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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 K152555
Device Name Dental Implant System
Applicant
Ariabio International, Inc.
229 Overland Ave., Suite 118
Los Angeles,  CA  90064
Applicant Contact Hagai Jacobsen
Correspondent
Talmed , Ltd.
Ramot Naftali, Upper Galilee
Ramot Naftali,  IL 13830
Correspondent Contact Tali Hazan
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/08/2015
Decision Date 02/11/2016
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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