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    K Number
    K972953
    Device Name
    PALAUREX 76KF
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PALAUREX 76KF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.

    Device Description

    Low gold palladium based casting alloy

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance:
    PropertyAcceptance Criteria (Predicate Device: Legacy XT)Reported Device Performance (Palaurex 76KF)
    Melting point range (solid.)1190 °C1115 °C
    Melting point range (liquid)1300 °C1285 °C
    Hardness (Vickers 5/30) - soft245220
    Hardness (Vickers 5/30) - hard(Not specified for predicate)260
    Yield strength (MPa) - soft552630
    Yield strength (MPa) - hard(Not specified for predicate)865
    Elongation (%) - soft3018
    Elongation (%) - hard(Not specified for predicate)4
    CTE (x10-6/°C)14.314.1
    Density (g/cm3)10.810.6
    Composition (weight%)
    Au22
    Ag107.5
    Pd75.475.6
    Sn02.9
    In66.2
    Ga65.5
    Ru
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