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510(k) Data Aggregation

    K Number
    K231264
    Device Name
    Easy On Universal Glaze & Stain
    Manufacturer
    Date Cleared
    2023-06-30

    (59 days)

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

    Doctus Global

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Easy On Universal Glaze & Stain is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
    Device Description
    Doctus Global offers two kinds of Easy On Universal Glaze & Stain: - V Easy On Universal Stain for artificial teeth - > Easy On Universal Gum Stain for dental prosthesis, artificial gum tissue portion. - V Easy Liners for Porcelain powder build-up process. - V Easy Add On for Correcting and Repair process. - > Easy On Crystal Glaze for glazing Lithium disilicate CAD/CAM block crown and bridge - V Build Up Liquid for porcelain powder build up process Both systems and other items are a useful finishing system made of paste type Stain & Glaze for dental ceramics. Fluorescent layering materials for staining and glazing. With Easy On Universal Stain & Gum Stain, you can easily and quickly achieve high quality dental ceramic prosthesis. Easy On Universal Stain consists of different types of self-glazing colors with various levels of translucency, each Unique replicate natural tooth shade and gum tissue colors and structures, such as incisal translucency, mamelons, detail expressions, halos, and gum tissue. Over paint Easy On Universal Stains we layer Easy On Universal Structures. With Easy On Universal Structure you can create tooth surface textures found in natural enamel area and gum tissues, in light and thin thicknesses of 0.1 mm - 0.3 mm. With easy applying and high stability. individual surface structures can easily be integrated into the paste with small brush. The low firing temperature does not change the details of the surface, so reliable and aesthetic results are achieved with one or two firings.
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