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

    SMILE WITH CONFIDENCE

    K Number: K971002 · Decision Jul 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    SMILE WITH CONFIDENCE
    K Number
    K971002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3540
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lloyd V. Ziemendorf
    Date Received
    March 19, 1997
    Decision Date
    July 15, 1997
    Product Code
    EHS
    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
    EHS Cushion, Denture, Over The Counter

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