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510(k) Data Aggregation

    K Number
    K193090
    Device Name
    HCG Zirconia Ceramic Block
    Manufacturer
    Hocheng Corporation
    Date Cleared
    2020-10-29

    (358 days)

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

    Hocheng Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HCG Zirconia Ceramic Block are intended for the fabrication of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
    Device Description
    "HCG Zirconia Ceramic Block" is a ceramic block composed of zirconia compounds. It is suitable for manufacture of dental crowns and bridges cut in the conventional manner or with the help of CAD/CAM.
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