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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 K240202
Device Name Conical Platform Dental Implants System
Applicant
Noris Medical , Ltd.
8 Hataasia St.
Nesher,  IL 3688808
Applicant Contact Noa Mor
Correspondent
Noris Medical , Ltd.
8 Hataasia St.
Nesher,  IL 3688808
Correspondent Contact Noa Mor
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/25/2024
Decision Date 06/06/2024
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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