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    K Number
    K242944
    Device Name
    Leone Orthodontic Implant TAD (Temporary Anchorage Device)
    Manufacturer
    Leone S.p.A.
    Date Cleared
    2025-06-19

    (267 days)

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

    Leone S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    Leone TADs are miniscrews made of titanium for surgical use (ISO 5832-3/ASTM F136). These orthodontic miniscrews are self-drilling with right-hand thread and they are available in an 8mm length. These devices are supplied sterile and sterilized by gamma irradiation.
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