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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.

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

The provided documentation (K140491) does not describe an AI medical device or a study proving its performance against acceptance criteria in the context of AI. Instead, it is a 510(k) premarket notification for dental products: "Tanaka ZirColor™ Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZR™ Blocks."

This document focuses on establishing substantial equivalence to previously cleared predicate devices (ZENO Zr Disc, Zenotec Color Zr, Zenostar Color Zr, Zenotec Zr Bridge, and Zenostar Zr Translucent cleared under K112710) based on intended use, technology, and performance, primarily through material composition and physicochemical testing, not AI performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device. The document simply does not contain this type of information.

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