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

    SET CANAL SEALER PASTE

    K Number: K862129 · Decision Jul 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    48

    Basic Information

    Device Name
    SET CANAL SEALER PASTE
    K Number
    K862129
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    ENDO TECHNIC CORP.
    Date Received
    June 4, 1986
    Decision Date
    July 22, 1986
    Product Code
    EKM
    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
    EKM Gutta-Percha

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