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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 K210852
Device Name Noris Medical Dental Implants System - Cortical
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 Received03/22/2021
Decision Date 06/24/2022
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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