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510(k) Data Aggregation

    K Number
    K200156
    Device Name
    Bright Low Flow
    Manufacturer
    Genoss co.,Ltd.
    Date Cleared
    2020-10-27

    (279 days)

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

    Genoss co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Class I, III, V (non-stress area, minimally invasive restoration) 2) Composite resin repair
    Device Description
    Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
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