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

    DYNA TRAK ENDODONTIC PREP. INSTRUMENT

    K Number: K812260 · Decision Aug 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    DYNA TRAK ENDODONTIC PREP. INSTRUMENT
    K Number
    K812260
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Inventive Technology Int'L., Inc.
    Date Received
    August 12, 1981
    Decision Date
    August 25, 1981
    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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