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510(k) Data Aggregation

    K Number
    K241602
    Device Name
    Kingcera Dental Zirconia Blank
    Date Cleared
    2024-08-30

    (87 days)

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

    Hunan Qinghao Puzhong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Kingcera Dental Zirconia Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
    Device Description
    Kingcera Dental Zirconia Blanks are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are further fabricated into various all-ceramic restorations such as crowns, bridges, veneers, and inlay/onlay. The zirconia powder is composed of ZrO2, HfO2, Y2O3, and other oxides; the performance of the Kingcera Dental Zirconia Blanks conforms to ISO 6872-2015. Dentistry: Ceramic Materials. Kingcera Dental Zirconia Blanks are ceramic dental blanks designed to manufacture ceramic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic devices are intended for single-use applications. At the dental lab, the blanks are held to t. Kingcera Dental Zirconia Blanks are supplied in different shapes, such as blocks, discs, rods, or customized shapes. They are provided in combinations of ninety-nine different colors and a gradual-changing translucency effect. The different constituents of color additives (such as Fe2O3); the different translucencies originate from a slight difference in the amount of Y203.
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