510(k) · Cleared
ClearedRazor, Everest, U&C Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&C International Co., Ltd. · EIH Powder, Porcelain
Cleared on Oct 11, 2019 as substantially equivalent to K143330 (Prismatik Dentalcraft, Inc., 2014) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Oct 11, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K060104 (2006). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- 2 generations backK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · Recalled
- 1 generation backK143330 BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014
- This deviceK191902 Razor, Everest, U&C LiquidU&C International Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060104 | Prismatik Clinical Zirconia | Glidewell Laboratories | 2006 | — |
| −2 | K130924 | Bruxzir Shaded | Prismatik Dentalcraft, Inc. | 2013 | 1 |
| −1 | K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | 2014 | — |
| 0 (this device) | K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K143330 | BruxZir AnteriorSummary page 4…Powder for Clinical Use ▪ Product Code: EIH ▪ Classification regulation: Class II, 21 CFR 872.6660 4. Predicate Device BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) by Talladium, Inc.… | 2014 |
| * | K143090 | Luminesse Pre-Sintered Zirconia Coloring LiquidSummary page 4…II, 21 CFR 872.6660 4. Predicate Device BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) by Talladium, Inc. 1 5. Description: Razor and Evere… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K143330.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
U&C Liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
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/K191902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191902: Razor, Everest, U&C Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191902
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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