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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 K191123
Device Name Multi-unit Abutments
Applicant
Medentika GmbH
Hammweg 8-10
Hügelsheim,  DE 76549
Applicant Contact Gerhard Polzer
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/29/2019
Decision Date 01/06/2020
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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