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510(k) Data Aggregation

    K Number
    K013824
    Device Name
    ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
    Manufacturer
    DENTAL MANUFACTURING S.P.A
    Date Cleared
    2002-01-30

    (72 days)

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

    DENTAL MANUFACTURING S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V and Z-TONE Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
    Device Description
    prefabricated devices, composed of methyl methacrylate material
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