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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 K223113
Device Name Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
Applicant
Medentika GmbH
Hammweg 8-10
Hugelsheim,  DE 76549
Applicant Contact Alexandra Schulz
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01801
Correspondent Contact Jennifer M Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/03/2022
Decision Date 04/15/2024
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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