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510(k) Data Aggregation

    K Number
    K060637
    Device Name
    DENFIL FLOW
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2006-03-16

    (6 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K993783
    Predicate For
    K140976,K192284
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Class V restorations (cervical caries, root erosion, wedge shaped defects)
    • Anterior restorations (Class III, IV)
    • Small posterior restorations
    • Restorative therapy for mini-cavities of all types
    • Extended fissures sealings in molars and premolars
    • Repair of composite/ceramic veneers
    • Blocking out of undercuts
    Device Description

    DenFil™ flow is a light-cured radio-opaque flowable restorative resin. It is composed of Epoxyacrylate(Bis-GMA), Diurethane dimethacrylate, Triethyleneglycol dimethacrylate, Barium aluminosilicate and other materials. As DenFil™ flow has a lower viscosity than paste type composite resin-Flow; 0.16 mm/30sec, so it can restore narrow & deep cavity easily. DenFil™ flow can be applied to fill cavities of all types exactly and efficiently by using a disposable tip. And DenFil™ flow has various shade that correspond to the most common used shading system.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental composite material called DenFil™ flow. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    The 510(k) summary focuses on demonstrating substantial equivalence between DenFil™ flow and a predicate device (Tetric Flow, K993783) based on similar technological characteristics (main material, chemical composition, radiopacity, visible light activation, and design) and mechanical properties (compressive strength, flexural strength, flow, film thickness, wear, polymerization shrinkage, and thermal expansion coefficient). It also mentions that safety tests, including biocompatibility, were performed to ensure compliance with regulations.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study as requested because this information is not present in the provided document.

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