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

    ENIGMA HI-BASE DENTURE BASE MATERIAL

    K Number: K993717 · Decision Dec 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    7
    Review Days
    49

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    Basic Information

    Device Name
    ENIGMA HI-BASE DENTURE BASE MATERIAL
    K Number
    K993717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Davis Schottlander & Davis, Ltd.
    Date Received
    November 3, 1999
    Decision Date
    December 22, 1999
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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