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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
Predetermined Change
Control Plan Authorized		 No
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