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

    Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)

    K Number: K210473 · Decision Nov 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    258

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    Basic Information

    Device Name
    Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
    K Number
    K210473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
    Date Received
    February 17, 2021
    Decision Date
    November 2, 2021
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

    K Number Device Name
    K220077 IMICRYL Composite, Composite Flow Materials
    K213609 NOVA RESIN dual cure, self adhesive resin cement
    K192913 R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
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