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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 K101913
Device Name ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
Applicant
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Applicant Contact ERIC GENEVE
Correspondent
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Correspondent Contact ERIC GENEVE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/08/2010
Decision Date 03/11/2011
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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