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510(k) Data Aggregation

    K Number
    K152023
    Device Name
    Luminesse Shaded Zirconia SZ
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2016-09-15

    (422 days)

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

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.
    Device Description
    Luminesse Shaded Zirconia SZ are used for full contour zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Shaded Zirconia SZ will undergo sintering. The shaded zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Shaded Zirconia SZ will exhibit maximum strength for posterior and anterior dental restorations.
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    K Number
    K152066
    Device Name
    Luminesse Anterior Zirconia AT
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2015-10-21

    (89 days)

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

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminesse Anterior Zirconia blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic custom dental restorations - full contour crowns and bridges for anterior location - as prescribed by a dentist.
    Device Description
    Luminesse Anterior Zirconia are used for full contour Zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Anterior Zirconia will undergo sintering. The anterior Zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Anterior Zirconia will exhibit maximum strength anterior dental restorations.
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    K Number
    K143090
    Device Name
    LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2015-06-15

    (230 days)

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

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.
    Device Description
    Luminesse® Pre-sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse® ZR blanks to provide individualized tooth (or teeth) shading. It is a liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks. Dental restorations are designed and manufactured by a certified dental professional (Technician) using CAD/CAM technology.
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    K Number
    K142371
    Device Name
    Luminesse PMMA
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2015-04-24

    (242 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.
    Device Description
    The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.
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    K Number
    K140848
    Device Name
    LUMINESSE PORCELAIN SYSTEM
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2014-12-17

    (258 days)

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

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
    Device Description
    The Luminesse Porcelain is dental porcelain used by dental technicians to create biocompatible crowns, bridges, and veneers. It consists of three categories: low fusing, high fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Powders, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.
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    K Number
    K100232
    Device Name
    LUMINESSE ZR BLANKS
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2010-05-21

    (115 days)

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

    TALLADIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL. After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.
    Device Description
    Luminesse Zirconia blanks, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque body allows intricate shapes to be machined with tight tolerances. Luminesse Zirconia blanks are phase stabilized with 3 mol % yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Luminesse Zirconia Blanks minimizing trace oxides. Luminesse Blanks are 99.9 wt% ZrO 2+ Y20 3 + HfO2 + A1203. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging. Luminesse Zirconia Blanks are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. All appliances are for the sole use of the particular patient only. A metal chuck is glued on the end of blank or a metal ring that holds it in the CAD/CAM machine which is used to machine the final dental restoration. After completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO 2. Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL. After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.
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