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510(k) Data Aggregation

    K Number
    K022299
    Device Name
    TRILUX, Z-TONE, ACRY ROCK
    Manufacturer
    RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO
    Date Cleared
    2002-10-07

    (83 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
    Device Description
    TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
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