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

    GLENROE GOLDEN ORTHODONTIC BRACKET

    K Number: K923124 · Decision Aug 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    102
    Applicant Total
    2
    Review Days
    62

    Basic Information

    Device Name
    GLENROE GOLDEN ORTHODONTIC BRACKET
    K Number
    K923124
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GLENROE
    Date Received
    June 26, 1992
    Decision Date
    August 27, 1992
    Product Code
    EJF
    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
    EJF Bracket, Metal, Orthodontic

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