BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    DENE BRIDGE

    K Number: K903672 · Decision Dec 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    DENE BRIDGE
    K Number
    K903672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dirotian Pty. , Ltd.
    Date Received
    August 14, 1990
    Decision Date
    December 5, 1990
    Product Code
    EKO
    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
    EKO Denture Preformed (Partially Prefabricated Denture)

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