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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K251220
Device Name NUVENTUS NV.C™ Prosthetic Components
Applicant
Infinitum Eta, Ltd.
Hatnufa 6
Petach Tikva,  IL 4951024
Applicant Contact Avital Barlev
Correspondent
Infinitum Eta, Ltd.
Hatnufa 6
Petach Tikva,  IL 4951024
Correspondent Contact Avital Barlev
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/21/2025
Decision Date 07/28/2025
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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