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

    CS-11

    K Number: K832500 · Decision Oct 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    92

    Basic Information

    Device Name
    CS-11
    K Number
    K832500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    CHEMA-SCUTUM, INC.
    Date Received
    July 27, 1983
    Decision Date
    October 27, 1983
    Product Code
    EBE
    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
    EBE Coating, Denture Hydrophilic, Resin

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