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

    JT-3 ELECTROGNATHOGRAPH

    K Number: K952218 · Decision Sep 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    133

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    Basic Information

    Device Name
    JT-3 ELECTROGNATHOGRAPH
    K Number
    K952218
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.2060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Research Associates, Inc.
    Date Received
    May 11, 1995
    Decision Date
    September 21, 1995
    Product Code
    NFS
    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
    NFS Device, Jaw Tracking, For Monitoring Jaw Positions

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