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

    AURECAST SUPER INLAY

    K Number: K001478 · Decision Jun 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    AURECAST SUPER INLAY
    K Number
    K001478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurex SA (Pty) , Ltd.
    Date Received
    May 11, 2000
    Decision Date
    June 20, 2000
    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 SA (Pty) , Ltd.

    K Number Device Name
    K001482 AURENORM 75 KF
    K001481 PALCERAM 49
    K001480 AURECAST 40 B
    K001479 PALCERAM 53
    K001477 AURELUX Y 84 PREMIUM