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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 K241575
Device Name Straumann® Anatomic Healing Abutments XC (AHA)
Applicant
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Applicant Contact Laura Bleyendaal
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/03/2024
Decision Date 11/11/2024
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
Recalls CDRH Recalls
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