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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 K170838
Device Name Medentika CAD/CAM TiBases
Medentika GmbH
AHammweg 8-10
Huegelsheim,  DE 76549
Applicant Contact Gerhard Polzer
Straumann USA, LLC
60-100 Minuteman Rd
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
Date Received03/21/2017
Decision Date 09/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No