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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K230104
Device Name Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
Applicant
Anthogyr
2237 Ave. André Lasquin
Sallanches,  FR 74700
Applicant Contact Estelle Salle
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/13/2023
Decision Date 10/16/2023
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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