510(k) · Cleared
ClearedDMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmax Co., Ltd. · EIH Powder, Porcelain
Cleared on Mar 8, 2018 as substantially equivalent to K143090 (Talladium, Inc., 2015) after an 87-day review. Its family tree reaches back 3 generations to 2013. 3 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K123680 (2013). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK123680 CoprancolorWhite Peaks Dental Systems GmbH & Co. KG · 2013
- 2 generations backK141723 Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014
- 1 generation backK143090 Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015
- This deviceK173769 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid…Dmax Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK223029 Perfit CLVatech Mcis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222961 Harvest Conceal ZR Block OutHarvest Dental Products, LLC · 2023
- Descendant · cites it directly · 0 of its ownK200131 BruxZir SteelPrismatik Dentalcraft, Inc. · 2020
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 | K123680 | Coprancolor | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| −2 | K141723 | Upcera Coloring Liquid (I and II ) | Liaoning Upcera Co., Ltd. | 2014 | — |
| −1 | K143090 | Luminesse Pre-Sintered Zirconia Coloring Liquid | Talladium, Inc. | 2015 | — |
| 0 (this device) | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon… | Dmax Co., Ltd. | 2018 | — |
| +1 | K223029 | Perfit CL | Vatech Mcis Co., Ltd. | 2023 | — |
| +1 | K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC | 2023 | — |
| +1 | K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K143090 | Luminesse Pre-Sintered Zirconia Coloring LiquidSummary page 4…Class II, 21 CFR 872.6660 Classification Product Code: EIH 4. Predicate Device: LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) by Talladium, Inc. 1… | 2015 |
What descends from it? (3)
3 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 5 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K223029 (Vatech Mcis Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143090.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DMAX coloring liquid, Chang’s liquid, Confident coloring liquid, and CAMeleon coloring liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173769: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173769
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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