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

    ENDODONTIC BROACH-BARBED BROACH

    K Number: K823489 · Decision Dec 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    6
    Applicant Total
    14
    Review Days
    22

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    Basic Information

    Device Name
    ENDODONTIC BROACH-BARBED BROACH
    K Number
    K823489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    November 23, 1982
    Decision Date
    December 15, 1982
    Product Code
    EKW
    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
    EKW Broach, Endodontic

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