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Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid and Tanaka Enamel Zr Blocks

by Tanaka Dental

510(k) K140491

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140491 Date20 May 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Tanaka ZirColor Coloring Liquid, Tanaka ZirColor Dipping Liquid and Tanaka Enamel ZR Blocks are dental products used to achieve desired colors on zirconia restorations. The coloring and dipping liquids are formulated in a range of incisal and gingival shades to match the classic A-D shade system.

These products are supplied in individual dipping jars and are intended for use with zirconia blocks. The device has received FDA 510k clearance. Users should refer to specific manufacturer part numbers for shade and volume requirements.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Tanaka ZirColor and Enamel ZR products used for?

    These products are designed for dental laboratory use to achieve specific colors on zirconia restorations. The system includes coloring and dipping liquids available in various incisal and gingival shades that correspond to the classic A-D shade system, intended for application with Tanaka Enamel ZR blocks.

  • How are these dental products supplied?

    The coloring and dipping liquids are supplied in individual dipping jars. Users should consult the specific manufacturer part numbers to determine the correct shade and volume required for their specific restorative procedures.

  • What is the regulatory status of the Tanaka ZirColor system?

    The Tanaka ZirColor Coloring Liquid, ZirColor Dipping Liquid, and Tanaka Enamel ZR Blocks have received FDA 510k clearance under the number K140491. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.