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510(k) Data Aggregation

    K Number
    K221429
    Device Name
    KDF Zirconia Disc
    Date Cleared
    2022-07-14

    (59 days)

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

    DENKEN-HIGHDENTAL Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.
    Device Description
    KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow. KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.
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