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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
6 0 Minuteman Rd.
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
Predetermined Change
Control Plan Authorized		 No
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