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

    REFURBISHED ORTHODONTIC APPLIANCES

    K Number: K913913 · Decision Nov 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    102
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    REFURBISHED ORTHODONTIC APPLIANCES
    K Number
    K913913
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ortho-Cycle Co.
    Date Received
    August 30, 1991
    Decision Date
    November 27, 1991
    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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