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

    BAND SEATER

    K Number: K951776 · Decision May 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    2
    Applicant Total
    40
    Review Days
    40

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    Basic Information

    Device Name
    BAND SEATER
    K Number
    K951776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ormco Corp.
    Date Received
    April 13, 1995
    Decision Date
    May 23, 1995
    Product Code
    ECR
    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
    ECR Setter, Band, Orthodontic

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