510(k) · Cleared
ClearedZenolux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EIH Powder, Porcelain
Cleared on May 24, 2013 as substantially equivalent to K082257 (Wieland Dental + Technik GmbH & Co. KG, 2008) and 4 other predicates after a 119-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- May 24, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K910611 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 3 generations backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- 2 generations backK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
- 1 generation backK053050 Procera Bridge AluminaNobel Biocare AB · 2006
- This deviceK130184 ZenoluxWieland Dental + Technik GmbH & Co. KG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −3 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| −2 | K041283 | Procera Bridge Zirconia | Nobel Biocare AB | 2004 | — |
| −1 | K053050 | Procera Bridge Alumina | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K130184 | Zenolux | Wieland Dental + Technik GmbH & Co. KG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K082257 | Zeno AI Eco DiscSummary page 1…er, Porcelain Product code: EIH C.D.R section: 872.6660 Classification: Class 11 Legally marketed equivalent device: ZENO Al eco Disc (K082257) (510(k) number) inCoris AL (K062506) Procera Bridge Alumina (K053050) C… | 2008 |
| * | K062506 | Incoris ALSummary page 1….R section: 872.6660 Classification: Class 11 Legally marketed equivalent device: ZENO Al eco Disc (K082257) (510(k) number) inCoris AL (K062506) Procera Bridge Alumina (K053050) Cercon ht (K1 12152) Z… | 2006 |
| * | K053050 | Procera Bridge AluminaSummary page 1…ss 11 Legally marketed equivalent device: ZENO Al eco Disc (K082257) (510(k) number) inCoris AL (K062506) Procera Bridge Alumina (K053050) Cercon ht (K1 12152) Zenostar Zr Translucent (K1 12710) Vi P… | 2006 |
| * | K112152 | Cercon HTSummary page 1…ZENO Al eco Disc (K082257) (510(k) number) inCoris AL (K062506) Procera Bridge Alumina (K053050) Cercon ht (K1 12152) Zenostar Zr Translucent (K1 12710) Vi Page 5-1 610 (k) Sum… | 2011 |
| * | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRSummary page 1…oris AL (K062506) Procera Bridge Alumina (K053050) Cercon ht (K1 12152) Zenostar Zr Translucent (K1 12710) Vi Page 5-1 610 (k) Summary Device description, Zenolux is a discoidal shaped,… | 2011 |
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 22 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 13 ancestors has a recall.
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?
Zenolux ame milling blanks, which ame intended to be used by professional dental technicians for the CAD/ CAM -fabrication of all-ceramic crowns and 3-unit bridges, in the anterior as well as posterior tooth region. These parts can be used as framework for veneering with suitable dental porcelain and/ or as full-contour monolithic restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130184: Zenolux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130184
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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