BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SOOTHE-N-SEAL CANKER SORE RELIEF

    K Number: K991923 · Decision Sep 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    87

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    Basic Information

    Device Name
    SOOTHE-N-SEAL CANKER SORE RELIEF
    K Number
    K991923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Closure Medical Corp.
    Date Received
    June 7, 1999
    Decision Date
    September 2, 1999
    Product Code
    MZW
    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
    MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

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