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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 K151590
Device Name Straumann RN Gold Abutment for Bridge
Applicant
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/12/2015
Decision Date 03/04/2016
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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