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510(k) Data Aggregation

    K Number
    K093571
    Device Name
    ZR DENTAL BLOCK
    Manufacturer
    AMS CO., LTD
    Date Cleared
    2010-03-12

    (114 days)

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

    AMS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges
    Device Description
    Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.
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