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

    AUROFLUID M, ALLOY NO. 5315

    K Number: K993475 · Decision Dec 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    67
    Review Days
    56

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    Basic Information

    Device Name
    AUROFLUID M, ALLOY NO. 5315
    K Number
    K993475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metalor Dental USA Corp.
    Date Received
    October 14, 1999
    Decision Date
    December 9, 1999
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

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