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

    WILLI GELLER CREATION II PORCELAIN

    K Number: K043468 · Decision Jan 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    WILLI GELLER CREATION II PORCELAIN
    K Number
    K043468
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jensen Int'L, Inc.
    Date Received
    December 16, 2004
    Decision Date
    January 12, 2005
    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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