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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 K190654
Device Name Straumann CI RD Ceramic Healing Caps
Applicant
Institut Straumann AG
Peter Merian-Weg 12
Basel,  CH CH-4002
Applicant Contact Pierre-Yves Calinon
Correspondent
StraumannUSA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/14/2019
Decision Date 06/28/2019
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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