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510(k) Data Aggregation

    K Number
    K180565
    Device Name
    PEAK NS033CF, PEAK NS017CF
    Manufacturer
    Date Cleared
    2018-06-13

    (100 days)

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

    Neosil Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    this device is to be used as a heavy body material for: - · Two step putty/wash technique - · Sigle step putty/wash technique - · Functional peripheries - Crown/bridge work
    Device Description
    Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly. To create the material, the user mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.
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    K Number
    K152180
    Device Name
    PEAK
    Manufacturer
    Date Cleared
    2015-10-22

    (79 days)

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

    Neosil Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NS033C is to be used as a light body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - · Silicon dental impressions - Crown/bridge work - Inlays, Onlays NS017C/NS017T 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 MSP is to be used as a putty body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - Inlays. Onlays MSBC is to be used as a bite type for: - Making accurate occlusal registrations - · Standards bite registrations in the end bite position. - · Key material for needle point registration. - Production of small model segments MSRC is to be used as a regular body material for: - Two step putty/wash technique - · Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, Onlays MSCC is to be used as a regular body material for: - Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - · Reline impressions - Crown/bridge work - Inlays. Onlays
    Device Description
    PEAK 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 PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon. PEAK offers one light body type: NS033C. PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance. PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly.
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