510(k) · Cleared
ClearedUpcera Glaze Paste, Glaze Powder, and Glaze Liquid
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 Sep 2, 2018 as substantially equivalent to K151731 (Genoss, 2016) after a 123-day review. Its family tree reaches back 2 generations to 2006. 3 later devices descend from it.
- Decided
- Sep 2, 2018
- Review
- 123 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060441 (2006). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK060441 Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model…Vident · 2006
- 1 generation backK151731 Rainbow Paste StainGenoss · 2016
- This deviceK181167 Upcera Glaze Paste, Glaze Powder, and Glaze LiquidLiaoning Upcera Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK260067 Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026
- Descendant · cites it directly · 0 of its ownK242400 Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK223192 XT Stain/GlazeShenzhen Xiangtong Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026 · cites it directly0descendants
- K242400Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K223192XT Stain/GlazeShenzhen Xiangtong Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060441 | Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX… | Vident | 2006 | — |
| −1 | K151731 | Rainbow Paste Stain | Genoss | 2016 | — |
| 0 (this device) | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd. | 2018 | — |
| +1 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026 | — |
| +1 | K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024 | — |
| +1 | K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K151731 | Rainbow Paste StainSummary page 4…II Regulation Number: 21 CFR 872.6660 Panel: Dental Product Code: EIH 5.5 Predicate Device Information: (1) K151731, “rainbow Paste Stain”, manufactured by “GENOSS Co., Ltd.” 5.6 Device Description: “Glaze Paste, Glaze Powder, and Glaze Liq… | 2016 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K260067 (Shandong Huge Dental Material Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151731.
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?
“Glaze Paste, Glaze Powder, and Glaze Liquid” are 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/K181167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181167: Upcera Glaze Paste, Glaze Powder, and Glaze Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181167
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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