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

    THERMOCRAFT PORCELAIN

    K Number: K840642 · Decision Mar 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    THERMOCRAFT PORCELAIN
    K Number
    K840642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    American Thermocraft Corp.
    Date Received
    February 15, 1984
    Decision Date
    March 30, 1984
    Product Code
    ELL
    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
    ELL Teeth, Porcelain

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