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

    DEN TEMP

    K Number: K821581 · Decision Jun 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    10
    Applicant Total
    3
    Review Days
    17

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    Basic Information

    Device Name
    DEN TEMP
    K Number
    K821581
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Majestic Drug Co., Inc.
    Date Received
    May 28, 1982
    Decision Date
    June 14, 1982
    Product Code
    EMB
    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
    EMB Zinc Oxide Eugenol

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