510(k) · Cleared
ClearedZirkonzahn Ice
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zirkonzahn GmbH · EIH Powder, Porcelain
Cleared on Sep 29, 2006 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 6 citing it directly.
- This deviceK061851 Zirkonzahn IceZirkonzahn GmbH · 2006
- Descendant · cites it directly · 12 of its ownK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK092513 Rainbow BlockGenoss Co., Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK152383 Ceramill Zolid FXEmergo Europe Consulting · 2015
- Descendant · 2 generations on · 2 of its ownK151842 Rainbow ShineGenoss · 2016
- Descendant · 3 generations on · 1 of its ownK170050 Z-CAD smileMetoxit AG · 2018
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K063511Ceramill ZIAmann Girrbach America, Inc. · 2007 · cites it directly12descendants
- K092513Rainbow BlockGenoss Co., Ltd. · 2009 · cites it directly5descendants
- K152383Ceramill Zolid FXEmergo Europe Consulting · 2015 · 2 generations on3descendants
- K151842Rainbow ShineGenoss · 2016 · 2 generations on2descendants
- K170050Z-CAD smileMetoxit AG · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061851 | Zirkonzahn Ice | Zirkonzahn GmbH | 2006 | — |
| +1 | K063511 | Ceramill ZI | Amann Girrbach America, Inc. | 2007 | — |
| +1 | K092513 | Rainbow Block | Genoss Co., Ltd. | 2009 | — |
| +2 | K152383 | Ceramill Zolid FX | Emergo Europe Consulting | 2015 | — |
| +2 | K151842 | Rainbow Shine | Genoss | 2016 | — |
| +3 | K170050 | Z-CAD smile | Metoxit AG | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (19)
See all 196 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, K063511 (Amann Girrbach America, Inc., 2007) has gone furthest, with 12 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.
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?
Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays
bonded dental restorations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061851: Zirkonzahn Ice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061851
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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