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

    NOVA RESIN dual cure, self adhesive resin cement

    K Number: K213609 · Decision Aug 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    267

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    Basic Information

    Device Name
    NOVA RESIN dual cure, self adhesive resin cement
    K Number
    K213609
    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
    November 15, 2021
    Decision Date
    August 9, 2022
    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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