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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 K150363
Device Name NOVA Dental Implants System
Applicant
NOVA Implants Ltd.
5 Yoni Nethanyhu Street
Or Yehuda,  IL 6037603
Applicant Contact Dan Grimberg
Correspondent
Sterling Medical Registration
22817 Ventura Blvd
Woodland Hills,  CA  91364
Correspondent Contact Daniela Levy
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/12/2015
Decision Date 06/29/2015
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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