510(k) · Cleared
ClearedUpcera Coloring Liquid (I and II )
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liaoning Upcera Co., Ltd. · EIH Powder, Porcelain
Cleared on Oct 22, 2014 as substantially equivalent to K123680 (White Peaks Dental Systems GmbH & Co. KG, 2013) after a 118-day review. Its family tree reaches back 1 generation to 2013. 11 later devices descend from it.
- Decided
- Oct 22, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123680 (2013). 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK123680 CoprancolorWhite Peaks Dental Systems GmbH & Co. KG · 2013
- This deviceK141723 Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK143090 Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK173769 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid…Dmax Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK232682 Pre-Sintered Zirconia Coloring LiquidChengdu Besmile Medical Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK261046 Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250534 Biomic Color OpaqueAidite (Qinhuangdao) Technology Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K143090Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015 · cites it directly5descendants
- K173769DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring LiquidDmax Co., Ltd. · 2018 · 2 generations on3descendants
- K232682Pre-Sintered Zirconia Coloring LiquidChengdu Besmile Medical Technology Co., Ltd. · 2024 · cites it directly1descendant
- K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd. · 2026 · cites it directly0descendants
- K250534Biomic Color OpaqueAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123680 | Coprancolor | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| 0 (this device) | K141723 | Upcera Coloring Liquid (I and II ) | Liaoning Upcera Co., Ltd. | 2014 | — |
| +1 | K143090 | Luminesse Pre-Sintered Zirconia Coloring Liquid | Talladium, Inc. | 2015 | — |
| +2 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon… | Dmax Co., Ltd. | 2018 | — |
| +1 | K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | 2024 | — |
| +1 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026 | — |
| +2 | K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K123680 | CoprancolorSummary page 4…Name: Powder, Porcelain Device Classification: II Regulation Number: 21 CFR 872.6660 Panel: General Dental Product Code: EIH 5.5 Predicate Device Information: (1) K123680, “CopranClor”, manufactured by “White Peaks Dental Systems Gmbh & Co. KG.” located in Essen, Germany 5.6 Device Description: U… | 2013 |
What descends from it? (11)
See all 115 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?
- Its one ancestor has no recall.
- Of its descendants, K143090 (Talladium, Inc., 2015) has gone furthest, with 5 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. 2014, 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?
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
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/K141723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141723: Upcera Coloring Liquid (I and II ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141723
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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