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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 K120792
Device Name TIXOS IMPLANT SYSTEM
Applicant
Leader Italia S.R.L.
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
Leader Italia S.R.L.
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact STUART R GOLDMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/15/2012
Decision Date 09/05/2012
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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