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

    DENTALIS KEZ ENDODONITC SEALER

    K Number: K971642 · Decision Jul 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    83

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    Basic Information

    Device Name
    DENTALIS KEZ ENDODONITC SEALER
    K Number
    K971642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neodental Chemical Products Co., Ltd.
    Date Received
    May 2, 1997
    Decision Date
    July 24, 1997
    Product Code
    EMA
    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
    EMA Cement, Dental

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