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

    BPA-FREE MICROHYBID COMPOSITE

    K Number: K120237 · Decision Dec 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    9
    Review Days
    320

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    Basic Information

    Device Name
    BPA-FREE MICROHYBID COMPOSITE
    K Number
    K120237
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novocol, Inc.
    Date Received
    January 26, 2012
    Decision Date
    December 11, 2012
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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