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510(k) Data Aggregation

    K Number
    K122972
    Device Name
    CDC ZIRCONIA BLANKS
    Manufacturer
    CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL
    Date Cleared
    2012-10-24

    (28 days)

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

    CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist. This product is for professional use only. Not for use by the general public or OTC.
    Device Description
    CDC Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for copings, inlays, crowns, and bridges.
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