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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 K153043
Device Name Noris Medical MBI Dental Implant System
Applicant
Noris Medical , Ltd.
8 Hataasia
Nesher,  IL 3688808
Applicant Contact Simha Sibony
Correspondent
Noris Medical , Ltd.
8 Hataasia
Nesher,  IL 3688808
Correspondent Contact Simha Sibony
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/19/2015
Decision Date 04/11/2016
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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