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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but this document is a letter from the FDA regarding the substantial equivalence of denture teeth. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies for an AI/ML device. Therefore, I cannot generate the requested output based on the provided text.

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