510(k) · Cleared
ClearedLuminesse Pre-Sintered Zirconia Coloring Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium, Inc. · EIH Powder, Porcelain
Cleared on Jun 15, 2015 as substantially equivalent to K141723 (Liaoning Upcera Co., Ltd., 2014) after a 230-day review. Its family tree reaches back 2 generations to 2013. 5 later devices descend from it.
- Decided
- Jun 15, 2015
- Review
- 230 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K123680 (2013). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK123680 CoprancolorWhite Peaks Dental Systems GmbH & Co. KG · 2013
- 1 generation backK141723 Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014
- This deviceK143090 Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK173769 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid…Dmax Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK223029 Perfit CLVatech Mcis Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222961 Harvest Conceal ZR Block OutHarvest Dental Products, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK200131 BruxZir SteelPrismatik Dentalcraft, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK191902 Razor, Everest, U&C LiquidU&C International Co., Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K173769DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring LiquidDmax Co., Ltd. · 2018 · cites it directly3descendants
- K223029Perfit CLVatech Mcis Co., Ltd. · 2023 · 2 generations on0descendants
- K222961Harvest Conceal ZR Block OutHarvest Dental Products, LLC · 2023 · 2 generations on0descendants
- K200131BruxZir SteelPrismatik Dentalcraft, Inc. · 2020 · 2 generations on0descendants
- K191902Razor, Everest, U&C LiquidU&C International Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K123680 | Coprancolor | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| −1 | K141723 | Upcera Coloring Liquid (I and II ) | Liaoning Upcera Co., Ltd. | 2014 | — |
| 0 (this device) | K143090 | Luminesse Pre-Sintered Zirconia Coloring Liquid | Talladium, Inc. | 2015 | — |
| +1 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon… | Dmax Co., Ltd. | 2018 | — |
| +2 | K223029 | Perfit CL | Vatech Mcis Co., Ltd. | 2023 | — |
| +2 | K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC | 2023 | — |
| +2 | K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. | 2020 | — |
| +1 | K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K141723 | Upcera Coloring Liquid (I and II )Summary page 5…cians for fabrication of all ceramic restorations for individual dental patients. Predicate Devices: Upcera Coloring Liquid (I and II)K141723 Performance Data: The materials and fabrication processes used in the manufacture of the sub… | 2014 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173769 (Dmax Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K141723.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143090: Luminesse Pre-Sintered Zirconia 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/K143090
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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