510(k) · Cleared
ClearedColor Liquid, Vita Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zirkonzahn Srl · EIH Powder, Porcelain
Cleared on Nov 22, 2019 as substantially equivalent to K182833 (The Argen Corporation, 2019) after a 263-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 22, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011394 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
- 2 generations backK111257 Heisenberg Dyeing Liquids3M Espe AG · 2011
- 1 generation backK182833 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier…The Argen Corporation · 2019
- This deviceK190518 Color Liquid, Vita LiquidZirkonzahn Srl · 2019
- Descendant · cites it directly · 1 of its ownK220960 BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK231347 BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220369 Esthetic ColorantKuraray Noritake Dental, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | Espe Dental AG | 2001 | — |
| −2 | K111257 | Heisenberg Dyeing Liquids | 3M Espe AG | 2011 | — |
| −1 | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ… | The Argen Corporation | 2019 | — |
| 0 (this device) | K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | 2019 | — |
| +1 | K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | 2022 | — |
| +2 | K231347 | BruxZir™ TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023 | — |
| +1 | K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic ReducerSummary page 5…ce Name: ArgenZ Liquid Shade, Argen Z Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer Product Code: EIH 510(k) Number: K182833 INDICATIONS FOR USE Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures. DEVICE DESCRIPTION Z… | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220960 (Prismatik Dentalcraft, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K182833.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190518: Color Liquid, Vita Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190518
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026