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

    MCSPADDEN CONDENSOR

    K Number: K791019 · Decision Aug 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    MCSPADDEN CONDENSOR
    K Number
    K791019
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Techdent, Inc.
    Date Received
    June 1, 1979
    Decision Date
    August 3, 1979
    Product Code
    EKR
    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
    EKR Plugger, Root Canal, Endodontic

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