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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 K161177
Device Name Axiom PX
Applicant
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Applicant Contact THERESE CANDAU
Correspondent
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Correspondent Contact THERESE CANDAU
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/26/2016
Decision Date 06/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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