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510(k) Data Aggregation

    K Number
    K170873
    Device Name
    Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
    Manufacturer
    Date Cleared
    2017-10-02

    (193 days)

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

    SwissMediTec GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - 1) Direct anterior and posterior restorations (including occlusal surfaces) - 2) Direct veneers - 3) Correction of tooth position and tooth shape - 4) Indirect restorations including inlays, onlays and veneers - 5) Intraoral repairs of fractured restorations - 6) Core build-ups - 7) Splinting
    Device Description
    The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips.
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