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510(k) Data Aggregation

    K Number
    K233125
    Device Name
    Zirconia Block
    Date Cleared
    2024-01-12

    (107 days)

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

    Hangzhou IVISTA Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
    Device Description
    Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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