BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE

    K Number: K970930 · Decision Apr 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    41

    Basic Information

    Device Name
    BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
    K Number
    K970930
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CLEFT PALATE APPLIANCES, INC.
    Date Received
    March 13, 1997
    Decision Date
    April 23, 1997
    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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