BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    EXPANSION SCREWS

    K Number: K925088 · Decision May 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    227

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    Basic Information

    Device Name
    EXPANSION SCREWS
    K Number
    K925088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Forestadent
    Date Received
    October 7, 1992
    Decision Date
    May 22, 1993
    Product Code
    DYJ
    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
    DYJ Retainer, Screw Expansion, Orthodontic

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