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510(k) Data Aggregation

    K Number
    K071490
    Device Name
    LEONE ORTHODONTIC MINI IMPLANT
    Manufacturer
    LEONE SPA
    Date Cleared
    2008-02-22

    (268 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEONE SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
    Device Description
    The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.
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    K Number
    K070483
    Device Name
    LEONE MONOIMPLANT FOR O-RING OVERDENTURE
    Manufacturer
    LEONE SPA
    Date Cleared
    2007-04-19

    (58 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEONE SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.
    Device Description
    The Leone Monoimplant for O-ring overdenture is a one-piece endosseous dental implant where an endosseous portion and an abutment portion are defined. The implant is composed of titanium alloy for surgical use. The endosseous portion is a self-tapping screw with a sandblasted surface, while the abutment portion is made of a smooth tapered neck favouring soft tissues healing and mucosal seal and a ball shape top for the connection to the overdenture's microhousing. The monoimplant is supplied in different sizes and is intended for use in the overdenture O-ring therapy in the treatment of the total lower edentulism.
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    K Number
    K050586
    Device Name
    LEONE IMPLANT SYSTEM
    Manufacturer
    LEONE SPA
    Date Cleared
    2006-02-27

    (357 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEONE SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leone Implant System is indicated for single or multiple tooth replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.
    Device Description
    The Leone implant system is composed of a fixture and an abutment joined together by a self locking tapered connection due to a Morse cone and a hexagon. The prosthesis is then placed over the abutment.
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