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510(k) Data Aggregation

    K Number
    K063511
    Device Name
    CERAMILL ZI
    Manufacturer
    AMANN GIRRBACH AMERICA, INC.
    Date Cleared
    2007-02-02

    (74 days)

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

    AMANN GIRRBACH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.
    Device Description
    The Ceramill Zi Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
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