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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    R&D Series Nova Compo N

    K Number: K192178 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    R&D Series Nova Compo N
    K Number
    K192178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
    Date Received
    August 12, 2019
    Decision Date
    December 20, 2019
    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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