# K140491: Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid and Tanaka Enamel ZR Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Tanaka Dental
- Decided: May 20, 2015 after 447 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011394 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 5.

## Indications for use
Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liquids 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.

Source page: https://510kreport.com/device/K140491
Methodology: https://510kreport.com/methodology