Skip to content

Color Liquid, Vita Liquid

by Zirkonzahn SRL

510(k) K190518

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 NumberK190518 Date22 Nov 2019ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Color Liquid, Vita Liquid is a liquid-based coloring agent for dental zirconia structures, classified as a dental material under the FDA’s Dental advisory committee. It is designed to infuse color into pre-sintered zirconia frameworks, enabling customization of shade and translucency for restorative applications in fixed prosthodontics.

This product is supplied as a liquid and is applied by dipping pre-sintered zirconia frameworks before the sintering process, allowing the liquid to penetrate and impart color. It is intended for single-use in dental laboratories and is regulated under the FDA 510(k) clearance (K190518) as a substantially equivalent dental device. No sterility or MRI safety information is specified in the provided data.

Other devices from Zirkonzahn GmbH

See all devices from Zirkonzahn GmbH →

Questions

AI-generated answers, 19 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 is the Color Liquid, Vita Liquid used for in dental restorations?

    The Color Liquid, Vita Liquid is a liquid coloring agent specifically designed to infuse color into pre-sintered zirconia frameworks. It allows dental laboratories to customize the shade and translucency of zirconia structures before the final sintering process, ensuring natural-looking results for fixed prosthodontics like crowns or bridges.

  • How is the Color Liquid, Vita Liquid applied in the dental lab?

    The product is applied by dipping pre-sintered zirconia frameworks into the liquid before the sintering process. This method allows the coloring agent to penetrate the zirconia, evenly distributing the desired shade and translucency for restorative applications.

  • Is the Color Liquid, Vita Liquid intended for reuse, or is it single-use?

    The Color Liquid, Vita Liquid is explicitly intended for single-use in dental laboratories. This ensures consistency in color application and maintains the integrity of the product for each batch of zirconia frameworks being treated.

  • What regulatory pathway does the Color Liquid, Vita Liquid follow?

    The Color Liquid, Vita Liquid is regulated under the FDA’s 510(k) clearance process, specifically classified under the Dental advisory committee. It was granted clearance as substantially equivalent to a predicate device, with the clearance number K190518, and follows a traditional review pathway.

  • Does the Color Liquid, Vita Liquid come in multiple shades or sizes?

    The provided data does not specify individual shade options or size variations for the Color Liquid, Vita Liquid. However, as a liquid coloring agent, it is likely formulated to achieve a range of customizable shades and translucencies when applied to pre-sintered zirconia frameworks, depending on the laboratory’s needs.