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    K Number
    K081253
    Device Name
    ZIRDENT CAD/CAM BLOCKS
    Manufacturer
    C5 MEDICAL WERKS, INC.
    Date Cleared
    2008-05-15

    (13 days)

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

    C5 MEDICAL WERKS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).
    Device Description
    ZirDent is a pre-formed machineable dental blank composed of zirconia ceramic (yttrium oxide stabilized zirconium oxide [YZTP]]. ZirDent is available in green (meaning "unfired") pre-formed blanks, partially-sintered (partially fired) pre-formed blanks and fully sintered (including hot isostatic press) pre-formed blanks. ZirDent is available in different shapes, shades, and dimensions according to the customers' / dental laboratories' specifications.
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