BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GK ALLOY

    K Number: K891390 · Decision Apr 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    GK ALLOY
    K Number
    K891390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    China Link, Inc.
    Date Received
    March 14, 1989
    Decision Date
    April 17, 1989
    Product Code
    EJJ
    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
    EJJ Alloy, Amalgam

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