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510(k) Data Aggregation

    K Number
    K221695
    Device Name
    3M Filtek Supreme Flowable Restorative
    Manufacturer
    3M Company ESPE Dental Products
    Date Cleared
    2022-06-13

    (3 days)

    Product Code
    EBF, EBC
    Regulation Number
    872.3690
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    Applicant Name (Manufacturer) :

    3M Company ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct Restoration of all cavity classes (I-V) - Base/liner under direct restorations - Repair of small defects in esthetic indirect restorations - Repair of resin and acrylic temporary materials - Pit and fissure sealant
    Device Description
    FiltekTM Supreme Flowable Restorative is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. It is available in a variety of tooth-colored shades. Filtek™ Supreme Flowable Restorative contains Bis GMA, TEGDMA, and Procrylat K resins. The fillers are a combination of an Ytterbium Fluoride filler, a non-agglomerated/non-aggregated surface-modified silica filler, and a surface-modified aggregated zirconia/silica cluster filler. The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). Filtek Supreme Flowable Restorative is applied to the tooth following the use of a methacrylate-based dental adhesive such as manufactured by 3M, which permanently bonds the restoration to the tooth structure. When irradiated by light, the methacrylate functionalities of the resin and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The product is available in both syringe and capsule delivery systems.
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