BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    AURELUX BIO Y85PF

    K Number: K972949 · Decision Sep 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    19
    Review Days
    90

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    Basic Information

    Device Name
    AURELUX BIO Y85PF
    K Number
    K972949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurex Precious Metal Industries (Pty)Ltd
    Date Received
    June 20, 1997
    Decision Date
    September 18, 1997
    Product Code
    EJT
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJT Alloy, Gold-Based Noble Metal

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    Other Clearances by Aurex Precious Metal Industries (Pty)Ltd

    K Number Device Name
    K972946 AURELUX 77
    K972945 AURENORM 68
    K972943 AURECAST 92
    K972953 PALAUREX 76KF
    K972951 HIPALLAUR 51
    K972956 PALCERAM 82SF
    K972955 PALCERAM 56
    K972954 PALAUREX 78
    K972950 HIPALLAUR 19
    K972952 AUREBOND 51
    Search all 19 clearances from Aurex Precious Metal Industries (Pty)Ltd →