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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 K241462
Device Name LONGY Implant and LONGY-N Implant
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 Biatrina Shidlovsky
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/23/2024
Decision Date 02/11/2025
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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