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

    S.T.P.B SOFT TISSUES PROTECTIVES BLADES

    K Number: K854467 · Decision Mar 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    S.T.P.B SOFT TISSUES PROTECTIVES BLADES
    K Number
    K854467
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6010
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Nortex USA, Inc.
    Date Received
    November 6, 1985
    Decision Date
    March 12, 1986
    Product Code
    EEJ
    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
    EEJ Guard, Disk