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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 K231072
Device Name Anthogyr FlexiBase® titanium bases for Axiom® BL
2237 Avenue André Lasquin
Sallanches,  FR 74700
Applicant Contact Estelle Salle
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson, MS
Regulation Number872.3630
Classification Product Code
Subsequent Product Code
Date Received04/14/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No