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510(k) Data Aggregation

    K Number
    K130654
    Device Name
    CRYSTAL ULTRA
    Date Cleared
    2013-09-24

    (196 days)

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

    DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns, and bridges. For use by or on the order of a dental professional.
    Device Description
    The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
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