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510(k) Data Aggregation

    K Number
    K042638
    Device Name
    RADIANCE PORCELAIN
    Manufacturer
    Date Cleared
    2004-12-17

    (81 days)

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

    AURIDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic porcelain system for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent. This porcelain system is a lower fusing porcelain than feldspar based porcelains and is manufactured from the fritting of manufactured glass compositions. In addition, it has lower opposing occlusal wear characteristics than feldspar based porcelains. Radiance is intended for use by dental laboratories as an alternative to other porcelains.
    Device Description
    Radiance Porcelain system is a sodium/potassium alumina silicate based leucite glass ceramic, porcelain system for the fabrication of either porcelain fused to metal or all ceramic restorations. Radiance porcelain can only be used with its corresponding leucite glass ceramic pressable, Press-I-Dent for the fabrication of all ceramic systems and therefore constitute one complete porcelain system.
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