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

    ENIGMA DENTURE TEETH

    K Number: K984128 · Decision Feb 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    54
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    ENIGMA DENTURE TEETH
    K Number
    K984128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3590
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Davis Schottlander & Davis, Ltd.
    Date Received
    November 18, 1998
    Decision Date
    February 9, 1999
    Product Code
    ELM
    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
    ELM Denture, Plastic, Teeth

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