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510(k) Data Aggregation

    K Number
    K062504
    Device Name
    CERAMAX
    Manufacturer
    ALPHADENT CO., LTD.
    Date Cleared
    2006-09-05

    (8 days)

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

    ALPHADENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.
    Device Description
    CeraMax is a dental material product composed of Feldspar, Quartz (SiO3), A1/O1, K-CO3, Na2CO1. SnO2 ZrO2 CeO2 LinCO2, BaCO1, CaCO2, H2BO3 and color pigments including Fluorolumin. It consists of Opaque (including Powder opaque, Paste opaque and Opaque modifier), Dentine (including Dentine modifier and Opacious Dentine), Enamel, Translucent, Cervical, Glaze and Stain. They are used by dental technicians for the preparation of crowns and bridges. It is used in prosthetic dentisty by heating the powder mixture to a high temperature in a furnace to produce a hard prosthesis with a glass-like finish.
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