BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ELEGANT

    K Number: K091826 · Decision Sep 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    471
    Applicant Total
    24
    Review Days
    98

    Basic Information

    Device Name
    ELEGANT
    K Number
    K091826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M ESPE AG DENTAL PRODUCTS
    Date Received
    June 19, 2009
    Decision Date
    September 25, 2009
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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