510(k) · Cleared
ClearedCeramill ZI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amann Girrbach America, Inc. · EIH Powder, Porcelain
Cleared on Feb 2, 2007 as substantially equivalent to K053438 (3M Espe AG Dental Products, 2006) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1998. 12 later devices descend from it.
- Decided
- Feb 2, 2007
- Review
- 74 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K980986 (1998). 5 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK980986 ProcadIvoclar USA, Inc. · 1998
- 1 generation backK053438 Glass Ceramics3M Espe AG Dental Products · 2006
- This deviceK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK092513 Rainbow BlockGenoss Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK152383 Ceramill Zolid FXEmergo Europe Consulting · 2015
- Descendant · 2 generations on · 2 of its ownK151842 Rainbow ShineGenoss · 2016
- Descendant · 2 generations on · 1 of its ownK170050 Z-CAD smileMetoxit AG · 2018
- Descendant · cites it directly · 1 of its ownK171876 Ceramill Zolid HT+ whiteAmann Girrbach AG · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092513Rainbow BlockGenoss Co., Ltd. · 2009 · cites it directly5descendants
- K152383Ceramill Zolid FXEmergo Europe Consulting · 2015 · cites it directly3descendants
- K151842Rainbow ShineGenoss · 2016 · 2 generations on2descendants
- K170050Z-CAD smileMetoxit AG · 2018 · 2 generations on1descendant
- K171876Ceramill Zolid HT+ whiteAmann Girrbach AG · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980986 | Procad | Ivoclar USA, Inc. | 1998 | — |
| −1 | K053438 | Glass Ceramics | 3M Espe AG Dental Products | 2006 | — |
| 0 (this device) | K063511 | Ceramill ZI | Amann Girrbach America, Inc. | 2007 | — |
| +1 | K092513 | Rainbow Block | Genoss Co., Ltd. | 2009 | — |
| +1 | K152383 | Ceramill Zolid FX | Emergo Europe Consulting | 2015 | — |
| +2 | K151842 | Rainbow Shine | Genoss | 2016 | — |
| +2 | K170050 | Z-CAD smile | Metoxit AG | 2018 | — |
| +1 | K171876 | Ceramill Zolid HT+ white | Amann Girrbach AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K032811 | FDA’s K032811 is Cedia Vancomycin Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K053438 | Glass CeramicsSummary page 1…6660 Class II medical device Product Code: EIH Panel: 76 Predicate devices: KaVo Everest ZS-Blank K03281 and 3M "Lava" K053438 and Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN… | 2006 |
| * | K052130 | Vita in-Ceram 2000 AL Cubes for Inlab, Models AL20/AL40Summary page 1…Panel: 76 Predicate devices: KaVo Everest ZS-Blank K03281 and 3M "Lava" K053438 and Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN ICE K061851, among others. Device description: The Ceramill Zi Blank is a pre-fo… | 2005 |
| * | K061851 | Zirkonzahn IceSummary page 1…S-Blank K03281 and 3M "Lava" K053438 and Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN ICE K061851, among others. Device description: The Ceramill Zi Blank is a pre-formed material for use by dental laboratories… | 2006 |
What descends from it? (12)
See all 124 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 9 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K092513 (Genoss Co., Ltd., 2009) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K053438.
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 | — |
What is it indicated for?
Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063511 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063511: Ceramill ZI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063511
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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