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

    ROOT CANAL FILES & REAMERS

    K Number: K770367 · Decision Mar 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    7

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    Basic Information

    Device Name
    ROOT CANAL FILES & REAMERS
    K Number
    K770367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Cemco Tool Co., Inc.
    Date Received
    February 22, 1977
    Decision Date
    March 1, 1977
    Product Code
    EKP
    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
    EKP Reamer, Pulp Canal, Endodontic

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