510(k) · Cleared
ClearedRainbow Paste Stain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss · EIH Powder, Porcelain
Cleared on Apr 15, 2016 as substantially equivalent to K060441 (Vident, 2006) after a 294-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.
- Decided
- Apr 15, 2016
- Review
- 294 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060441 (2006). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK060441 Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model…Vident · 2006
- This deviceK151731 Rainbow Paste StainGenoss · 2016
- Descendant · cites it directly · 3 of its ownK181167 Upcera Glaze Paste, Glaze Powder, and Glaze LiquidLiaoning Upcera Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK260067 Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK242400 Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233885 rainbow Paste Stain SEGenoss Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK223192 XT Stain/GlazeShenzhen Xiangtong Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidLiaoning Upcera Co., Ltd. · 2018 · cites it directly3descendants
- K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026 · 2 generations on0descendants
- K242400Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
- K233885rainbow Paste Stain SEGenoss Co., Ltd. · 2024 · cites it directly0descendants
- K223192XT Stain/GlazeShenzhen Xiangtong Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060441 | Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX… | Vident | 2006 | — |
| 0 (this device) | K151731 | Rainbow Paste Stain | Genoss | 2016 | — |
| +1 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd. | 2018 | — |
| +2 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026 | — |
| +2 | K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024 | — |
| +1 | K233885 | rainbow Paste Stain SE | Genoss Co., Ltd. | 2024 | — |
| +2 | K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K060441 | Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX…Summary page 4…ion name : Porcelain powder for clinical use Product code : EIH Device class : Class II 3. Predicate Device K060441 Primary predicate K052710 Reference predicate 4. Description rainbowTM Paste Stain is a dental ve… | 2006 |
| † | K052710 | Vita VM7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX… | 2006 |
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?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
rainbowTM Paste Stain is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151731: Rainbow Paste Stain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151731
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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