510(k) · Cleared
ClearedCoprancolor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
White Peaks Dental Systems GmbH & Co. KG · EIH Powder, Porcelain
Cleared on Feb 21, 2013 after an 83-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Feb 21, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK123680 CoprancolorWhite Peaks Dental Systems GmbH & Co. KG · 2013
- Descendant · cites it directly · 11 of its ownK141723 Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014
- Descendant · 2 generations on · 5 of its ownK143090 Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK173769 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid…Dmax Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK232682 Pre-Sintered Zirconia Coloring LiquidChengdu Besmile Medical Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK261046 Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K141723Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014 · cites it directly11descendants
- K143090Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015 · 2 generations on5descendants
- K173769DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring LiquidDmax Co., Ltd. · 2018 · 3 generations on3descendants
- K232682Pre-Sintered Zirconia Coloring LiquidChengdu Besmile Medical Technology Co., Ltd. · 2024 · 2 generations on1descendant
- K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123680 | Coprancolor | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| +1 | K141723 | Upcera Coloring Liquid (I and II ) | Liaoning Upcera Co., Ltd. | 2014 | — |
| +2 | K143090 | Luminesse Pre-Sintered Zirconia Coloring Liquid | Talladium, Inc. | 2015 | — |
| +3 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon… | Dmax Co., Ltd. | 2018 | — |
| +2 | K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | 2024 | — |
| +2 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | ZENOTEC Zr / ZENOSTAR Color Zr Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141723 | Upcera Coloring Liquid (I and II ) | 2014 | 11 |
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?
- Of its descendants, K141723 (Liaoning Upcera Co., Ltd., 2014) has gone furthest, with 11 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. 2013, 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?
CopranColor is intended to be used as the coloring agent for the shading of white zirconia. ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123680: Coprancolor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123680
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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