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510(k) Data Aggregation

    K Number
    K092630
    Device Name
    ZIROX
    Manufacturer
    ZENCERA INC
    Date Cleared
    2009-10-22

    (56 days)

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

    ZENCERA INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
    Device Description
    ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height). ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX 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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