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

    DENTAL PORCELAIN-VARIOUS

    K Number: K851733 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    174

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    Basic Information

    Device Name
    DENTAL PORCELAIN-VARIOUS
    K Number
    K851733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Excelco Intl., Inc.
    Date Received
    April 25, 1985
    Decision Date
    October 16, 1985
    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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