510(k) · Cleared
ClearedLuxer Shaded Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Continental Dental Ceramics, Inc. · EIH Powder, Porcelain
Cleared on May 7, 2014 as substantially equivalent to K112710 (Wieland Dental + Technik GmbH & Co. KG, 2011) after a 114-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- May 7, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011394 (2001). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
- 1 generation backK112710 Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR…Wieland Dental + Technik GmbH & Co. KG · 2011
- This deviceK140070 Luxer Shaded ZirconiaContinental Dental Ceramics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK172761 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded &…Shanghai New Century Dental Materials Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK192535 Unshaded Dental Zirconia and Pre-Shaded Dental ZirconiaQinhuangdao Audental Metal Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK181816 Ceramic Denture Zirconia Ceramics BlockQinhuangdao Silide Ceramic Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK161025 priti multidisc ZrO2 High TranslucentPritidenta GmbH · 2017
Most influential descendants
Showing 4 of 4 · See all- K172761New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)Shanghai New Century Dental Materials Co., Ltd. · 2017 · cites it directly2descendants
- K192535Unshaded Dental Zirconia and Pre-Shaded Dental ZirconiaQinhuangdao Audental Metal Technology Co., Ltd. · 2020 · 2 generations on0descendants
- K181816Ceramic Denture Zirconia Ceramics BlockQinhuangdao Silide Ceramic Technology Co., Ltd. · 2018 · 2 generations on0descendants
- K161025priti multidisc ZrO2 High TranslucentPritidenta GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | Espe Dental AG | 2001 | — |
| −1 | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR | Wieland Dental + Technik GmbH & Co. KG | 2011 | — |
| 0 (this device) | K140070 | Luxer Shaded Zirconia | Continental Dental Ceramics, Inc. | 2014 | — |
| +1 | K172761 | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) | Shanghai New Century Dental Materials Co., Ltd. | 2017 | — |
| +2 | K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia | Qinhuangdao Audental Metal Technology Co., Ltd. | 2020 | — |
| +2 | K181816 | Ceramic Denture Zirconia Ceramics Block | Qinhuangdao Silide Ceramic Technology Co., Ltd. | 2018 | — |
| +1 | K161025 | priti multidisc ZrO2 High Translucent | Pritidenta GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRSummary page 1…ame: Powder, Porcelain Classification: Class 11 Panel: Dental S. Predicate Device: K112710 -ZENQ Zr Wieland Dental + Technik GmbH & Co. KG 6. Description of Medical Device:… | 2011 |
What descends from it? (4)
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K172761 (Shanghai New Century Dental Materials Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K112710.
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?
Luxer Shaded Zirconia blanks are Intended for use with CAD/CAM technology to produce all
ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140070: Luxer Shaded Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140070
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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