BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FILAFEX ESTHETIC ORTHODINIC WIRE

    K Number: K833788 · Decision Jan 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    29
    Applicant Total
    3
    Review Days
    85

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    Basic Information

    Device Name
    FILAFEX ESTHETIC ORTHODINIC WIRE
    K Number
    K833788
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Berkley and Co.
    Date Received
    October 31, 1983
    Decision Date
    January 24, 1984
    Product Code
    DZC
    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
    DZC Wire, Orthodontic

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    Other Clearances by Berkley and Co.

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