510(k) · Cleared
ClearedKavo Everest ZS-Blank Models, 42, 20, and 60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America · EIH Powder, Porcelain
Cleared on Jul 24, 2003 as substantially equivalent to K030607 (Kavo America, 2003) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it.
- Decided
- Jul 24, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022996 (2002). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
- This deviceK032081 Kavo Everest ZS-Blank Models, 42, 20, and 60Kavo America · 2003
- Descendant · cites it directly · 2 of its ownK091096 Naturaz Series, Model B16,B20, B42, B60, B98, B100Dental Solutions, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK161219 Zmaxx T SeriesMaxx Digm, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK250826 Multi M SeriesDmax Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK063624 Kavo Everest C-TempKavo America · 2007
- Descendant · cites it directly · 0 of its ownK033221 Kavo Everest ZH-BlankKavo America Corporation · 2003
Most influential descendants
Showing 5 of 5 · See all- K091096Naturaz Series, Model B16,B20, B42, B60, B98, B100Dental Solutions, Inc. · 2009 · cites it directly2descendants
- K161219Zmaxx T SeriesMaxx Digm, Inc. · 2017 · 2 generations on1descendant
- K250826Multi M SeriesDmax Co., Ltd. · 2025 · 3 generations on0descendants
- K063624Kavo Everest C-TempKavo America · 2007 · cites it directly0descendants
- K033221Kavo Everest ZH-BlankKavo America Corporation · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022996 | Vita in-Ceram YZ Cubes for Cerec | Vident | 2002 | — |
| 0 (this device) | K032081 | Kavo Everest ZS-Blank Models, 42, 20, and 60 | Kavo America | 2003 | — |
| +1 | K091096 | Naturaz Series, Model B16,B20, B42, B60, B98, B100 | Dental Solutions, Inc. | 2009 | — |
| +2 | K161219 | Zmaxx T Series | Maxx Digm, Inc. | 2017 | — |
| +3 | K250826 | Multi M Series | Dmax Co., Ltd. | 2025 | — |
| +1 | K063624 | Kavo Everest C-Temp | Kavo America | 2007 | — |
| +1 | K033221 | Kavo Everest ZH-Blank | Kavo America Corporation | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K030607 | Kavo Everest G-Blank, Kavo Everest G-Ceram, Coating Ceramic LF-3-PFM, Glaze and… | 2003 |
| * | K022996 | Vita in-Ceram YZ Cubes for CerecSummary page 1…device Product Code: EIH Panel: 76 Predicate devices: KaVo Everest G-Blank KO30607 and Vita inCeram Zirconia, K022996, among others, Device description: The KaVo Everest@ ZS-Blank is a pre-formed material for use by dental… | 2002 |
What descends from it? (5)
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?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 KaVo Everest@ ZS-Blank is used in the manufacture of dental prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032081: Kavo Everest ZS-Blank Models, 42, 20, and 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032081
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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