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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 K180564
Device Name Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
Applicant
Medentika GmbH
Hammweg 8-10
Huegelsheim,  DE 76549
Applicant Contact Gerhard Polzer
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/05/2018
Decision Date 01/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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