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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 K213063
Device Name TLX SRAs and TLX Gold Abutments
Applicant
Institut Straumann AG
Peter Merian Weg 12
Basel,  CH CH-4002
Applicant Contact Gina Chang
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer M Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/23/2021
Decision Date 04/08/2022
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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