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    K Number
    K220077
    Device Name
    IMICRYL Composite, Composite Flow Materials
    Date Cleared
    2022-08-09

    (211 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe) - · Direct anterior & posterior restorations - · Core Build Ups - · Splinting IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza) - · Class III, V & smaller Class IV restorations - · Base/liner in Class I & Class II restorations - · Repair resin, porcelain & acrylic temporary materials - · Pit & fissure sealant - · Undercut blockout - Restoration of minimally invasive cavity preparations
    Device Description
    IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light. IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity. There are differences in viscosity between composites and flowable composites.
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