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510(k) Data Aggregation

    K Number
    K981524
    Device Name
    PRILANE
    Date Cleared
    1998-07-10

    (73 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRESCO PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prilane is indicated as part of a system to repair fractured dental porcelain and to bond all porcelain restorations. The system involves etching the porcelain and then applying a small amount of Prilane to the etched surface.
    Device Description
    Prilane is a silane coupler, a device that when applied to inorganic surfaces such as dental porcelain, will chemically bond to the porcelain and will then bond to the organic thermoset resins that are commonly used as luting agents and restorative materials in dentistry. The above results in: Improved adhesion. Increased composite wet & dry strength. Increased composite wet & dry flexural strength. Prilane is a clear, low viscosity liquid having a pH of 6. Prilane is a prehydrolized silane. The hydrolization involves adding a small amount of water (.125%) to the silane. The hydrolization reaction causes the silane to be both organic and inorganic reactive. The silane material is Dow Corning Z-6030 which is -methacryloxypropyctrimethoxy silane.
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