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510(k) Data Aggregation

    K Number
    K973542
    Device Name
    MASKY
    Manufacturer
    PRESSING DI MONTICELLI RAG. STEFANO
    Date Cleared
    1998-02-10

    (145 days)

    Product Code
    EBIDAT
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRESSING DI MONTICELLI RAG. STEFANO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.
    Device Description
    Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.
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