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    K Number
    K133178
    Device Name
    LUXATOR LX HANDPIECE
    Manufacturer
    DIRECTA AB
    Date Cleared
    2015-11-24

    (768 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIRECTA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.
    Device Description
    Not Found
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