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510(k) Data Aggregation

    K Number
    K140491
    Device Name
    TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
    Manufacturer
    Date Cleared
    2015-05-20

    (447 days)

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

    TANAKA DENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liguids for the shading of white zirconia ceramic materials. This product is intended to be used by professional dental technicians for fabrication of all-ceramic single tooth crown and bridgework restorations. Tanaka Enamel ZR™ Blocks are yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) ceramic (zirconia) blanks intended to be used by professional dental technicians for the fabrication of all-ceramic restorations. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region.
    Device Description
    Tanaka ZirColor™ Coloring Liquid is supplied as twenty different shades (4 ml each) of metallic oxide based liguid used for the shading of white zirconia ceramic materials. The liquid is identified as the following twenty shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, Occlusal, C1, C2, C3, C4, D2, D3, D4 Incisal Dk, Incisal Lt and Pink. A liquid thinner agent comprised solely of the base component contained in the Tanaka ZirColor™ Coloring Liquid (15 ml), and 2 birch wood handle brushes for the application of the coloring agent also are supplied. Tanaka ZirColor™ Dipping Liquid (50% diluted formulation of the Tanaka ZirColor™ Coloring Liquid) is supplied as sixteen different shades (30 ml each) of metallic oxide based liquid used for the shading of white zirconia ceramic materials. The Tanaka ZirColor™ Dipping Liquid is identified as the following sixteen shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4. Tanaka Enamel ZR™ Blocks are yttria-stabilized zirconium dioxide (Y -TZP) ceramic (zirconia) blanks supplied in the following five shades: neutral, light, medium, dark and body. These shades are achieved by using the different shades of ZirColor™ Liquid noted above. The zirconia blanks are provided as the following ten sizes: No. 01 98.25 +/- 0.2 mm 10.0+/- 0.1 mm No. 02 98.25 +/- 0.2 mm 12.0+/- 0.1 mm No. 03 98.25 +/- 0.2 mm 14.0+/- 0.1 mm No. 04 98.25 +/- 0.2 mm 16.0+/- 0.1 mm No. 05 98.25 +/- 0.2 mm 18.0+/- 0.1 mm No. 06 98.25 +/- 0.2 mm 20.0+/- 0.1 mm No. 07 98.25 +/- 0.2 mm 22.0+/- 0.1 mm No. 08 98.25 +/- 0.2 mm 24.0+/- 0.1 mm No. 09 98.25 +/- 0.2 mm 26.0+/- 0.1 mm No. 10 98.25 +/- 0.2 mm 29.0+/- 0.1 mm
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