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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 K070483
Device Name LEONE MONOIMPLANT FOR O-RING OVERDENTURE
Applicant
Leone S.P.A.
50, Via P. A Quaracchi
Sesto, Fiorentino,  IT I-50019
Applicant Contact ELIA LADANI
Correspondent
Leone S.P.A.
50, Via P. A Quaracchi
Sesto, Fiorentino,  IT I-50019
Correspondent Contact ELIA LADANI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/20/2007
Decision Date 04/19/2007
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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