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

    NICKEL-TITANIUM K-TYPE FILE

    K Number: K935542 · Decision Jan 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    14
    Review Days
    48

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    Basic Information

    Device Name
    NICKEL-TITANIUM K-TYPE FILE
    K Number
    K935542
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    November 16, 1993
    Decision Date
    January 3, 1994
    Product Code
    EKS
    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
    EKS File, Pulp Canal, Endodontic

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