510(k) · Cleared
ClearedZeno ZR Disc
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 Nov 21, 2007 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK073108 Zeno ZR DiscWieland Dental + Technik GmbH & Co. KG · 2007
- Descendant · cites it directly · 3 of its ownK092496 Copran ZR/Origin YZWhite Peaks Dental Systems GmbH & Co. KG · 2009
- Descendant · 2 generations on · 2 of its ownK140877 Vericore Zirconia BlanksWhip Mix Corp. · 2014
- Descendant · 3 generations on · 1 of its ownK142670 Vericore Zirconia BlanksWhip Mix Corporation · 2014
- Descendant · cites it directly · 1 of its ownK081749 Avante Z Zirconia (as)3 BlocksPentron Ceramics, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK152443 Vericore Gradient Temporary DiscWhip Mix Corporation · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092496Copran ZR/Origin YZWhite Peaks Dental Systems GmbH & Co. KG · 2009 · cites it directly3descendants
- K140877Vericore Zirconia BlanksWhip Mix Corp. · 2014 · 2 generations on2descendants
- K142670Vericore Zirconia BlanksWhip Mix Corporation · 2014 · 3 generations on1descendant
- K081749Avante Z Zirconia (as)3 BlocksPentron Ceramics, Inc. · 2008 · cites it directly1descendant
- K152443Vericore Gradient Temporary DiscWhip Mix Corporation · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073108 | Zeno ZR Disc | Wieland Dental + Technik GmbH & Co. KG | 2007 | — |
| +1 | K092496 | Copran ZR/Origin YZ | White Peaks Dental Systems GmbH & Co. KG | 2009 | — |
| +2 | K140877 | Vericore Zirconia Blanks | Whip Mix Corp. | 2014 | — |
| +3 | K142670 | Vericore Zirconia Blanks | Whip Mix Corporation | 2014 | — |
| +1 | K081749 | Avante Z Zirconia (as)3 Blocks | Pentron Ceramics, Inc. | 2008 | — |
| +4 | K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K092496 (White Peaks Dental Systems GmbH & Co. KG, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 | — |
https://510kreport.com/device/K073108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073108: Zeno ZR Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073108
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026