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510(k) Data Aggregation

    K Number
    K140070
    Device Name
    LUXER SHADED ZIRCONIA
    Manufacturer
    CONTINENTAL DENTAL CERAMICS, INC.
    Date Cleared
    2014-05-07

    (114 days)

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

    CONTINENTAL DENTAL CERAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luxer Shaded Zirconia blanks/discs are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.
    Device Description
    Luxer Shaded Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. It comes in different thicknesses (12 mm - 20 mm) and classic VITA shades A-D. In order to achieve pigmentation, four basic color components are used from the TOSOH TZ-Series of zirconia {white, yellow, pink, and gray} that yield corresponding VITA shades (A-D). After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for full contour crowns and bridges. The material is biocompatible, has a high flexural strength (>1100 Mpa), and is water insoluble. These characteristics meet the ISO standard 6872 for an esthetic dental ceramic material.
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    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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