510(k) · Cleared
ClearedArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Argen Corporation · EIH Powder, Porcelain
Cleared on Feb 8, 2019 as substantially equivalent to K111257 (3M Espe AG, 2011) after a 122-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Feb 8, 2019
- Review
- 122 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011394 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
- 1 generation backK111257 Heisenberg Dyeing Liquids3M Espe AG · 2011
- This deviceK182833 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier…The Argen Corporation · 2019
- Descendant · cites it directly · 3 of its ownK190518 Color Liquid, Vita LiquidZirkonzahn Srl · 2019
- Descendant · 2 generations on · 1 of its ownK220960 BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK231347 BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK230262 BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220369 Esthetic ColorantKuraray Noritake Dental, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K190518Color Liquid, Vita LiquidZirkonzahn Srl · 2019 · cites it directly3descendants
- K220960BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. · 2022 · 2 generations on1descendant
- K231347BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. · 2023 · 3 generations on0descendants
- K230262BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. · 2023 · cites it directly0descendants
- K220369Esthetic ColorantKuraray Noritake Dental, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | Espe Dental AG | 2001 | — |
| −1 | K111257 | Heisenberg Dyeing Liquids | 3M Espe AG | 2011 | — |
| 0 (this device) | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ… | The Argen Corporation | 2019 | — |
| +1 | K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | 2019 | — |
| +2 | K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | 2022 | — |
| +3 | K231347 | BruxZir™ TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023 | — |
| +1 | K230262 | BruxZir™ Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023 | — |
| +2 | K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K111257 | Heisenberg Dyeing LiquidsSummary page 5…ted devices for which our organization is claiming substantial equivalence: 510(k) Trade Name Manufacturer Number K111257 HEISENBERG DYEING LIQUIDS 3M ESPE AG Device Description: ArgenZ Zirconia Coloring Liquids ar… | 2011 |
What descends from it? (5)
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 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190518 (Zirkonzahn Srl, 2019) has gone furthest, with 3 descendants of its own.
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?
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ frameworks and ArgenZ all-zirconia, monolithic restorations for anterior and posterior dental prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182833: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182833
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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