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510(k) Data Aggregation

    K Number
    K143382
    Device Name
    DentiAnn Smart Sil
    Date Cleared
    2015-02-23

    (90 days)

    Product Code
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SeilGlobal Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DentiAnn Light-body is to be used as a light body material for: - Two step putty/wash technique - · Single step putty/wash technique - Functional peripheries - Reline impressions - = Crown/bridge work - Inlays, Onlays DentiAnn Heavy-body is to be used as a heavy body material for: - · Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - Inlays, Onlays SmartSil-Putty is to be used as a preliminary material for: - · Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - · Inlays, Onlays SmartSil-Bite is to be used as a light body material for: - = Making accurate occlusal registrations - Standards bite registrations in the end bite position. - · Key material for needle point registration. - · Production of small model segments
    Device Description
    DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.
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