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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 K141450
Device Name AXIOM 2.8
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  
Subsequent Product Code
NHA  
Date Received06/02/2014
Decision Date 09/17/2014
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
Recalls CDRH Recalls
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