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510(k) Data Aggregation

    K Number
    K180463
    Device Name
    Apoller Flow Light Cure Flowable Composite
    Manufacturer
    Date Cleared
    2018-11-14

    (266 days)

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

    Greenway YW LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use: *Class III and V restorations - * Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) *Base/liner under direct restorations *Repair of small defects in esthetic indirect restorations *Pit and fissure sealant *Undercut blockout *Repair of resin and acrylic temporary materials
    Device Description
    Apoller Flow-Light Cure Flowable Composite is a low viscosity light activated flowable nanocomposite device. The device is comprised of a syringe with dispensing tips. It consists of methmethacrylate monomers, inorganic fillers and nanoparticles. Apoller Flow Light Cure Flowable Composite contains BisGMA, UDMA, TEGDMA, photo initiator, stabilizer and inorganic fillers including barium glass powder, strontium glass powder and nanosilica. The filler loading is about 56% by weight. The particle size varies from 0.03 to 1 micron. Apoller Flow Light Cure Flowable Composite series is packed in a plastic syringe with a bend metal injection needle heads for ease of usage, its model is Flowable and comes with Refill Syringe of 3.0g /syringe and 1.5 g /syringe. It is available in a variety of 15 tooth-colored shades.
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