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

    FLEXIDENT DENTURE

    K Number: K760768 · Decision Oct 15, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    11

    Basic Information

    Device Name
    FLEXIDENT DENTURE
    K Number
    K760768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Flexodent Corp.
    Date Received
    October 4, 1976
    Decision Date
    October 15, 1976
    Product Code
    EKO
    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
    EKO Denture Preformed (Partially Prefabricated Denture)

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