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510(k) Data Aggregation

    K Number
    K192535
    Device Name
    Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
    Date Cleared
    2020-01-31

    (137 days)

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

    Qinhuangdao Audental Metal Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
    Device Description
    The Dental Zirconia are intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. The Dental Zirconia divided into two categories: Unshaded (Model: DUT) and Pre-Shaded (Model: DUTC). Both Unshaded Dental Zirconia (Model: DUT) and Pre-Shaded Dental Zirconia (Model: DUTC) are available in discs shape, and in various specifications, which are shares same diameter (98 mm) and combinations of height (10-25 mm). The color model for pre-shaded dental zirconia includes A1; A2; A3; A3.5; B2; C2; 1M1; 1M2; 2L1.5; 2M2; 3M2; 3M3; 4M2; 5M3 for difference color. Both Unshaded Dental Zirconia (Model: DUT) and Pre-Shaded Dental Zirconia (Model: DUTC) have same base materials and derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder of Dental Zirconia is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Dental Zirconia conforms to ISO 6872:2015 Dentistry: Ceramic Materials. The Dental Zirconia are disposable device, and provided as non-sterile
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