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510(k) Data Aggregation

    K Number
    K083201
    Device Name
    ZMATCH BLOCK
    Manufacturer
    Date Cleared
    2009-01-26

    (88 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAIM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations. The Zmatch® Block is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
    Device Description
    Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition. Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.
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