510(k) · Cleared
ClearedWilli Geller Creation ZI Porcelain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jensen Industries, Inc. · EIH Powder, Porcelain
Cleared on Jan 11, 2005 as substantially equivalent to K002041 (Jensen Industries, Inc., 2000) after a 54-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.
- Decided
- Jan 11, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002041 (2000). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002041 Willi Geller Creation & AV PorcelainJensen Industries, Inc. · 2000
- This deviceK043201 Willi Geller Creation ZI PorcelainJensen Industries, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- Descendant · 2 generations on · 7 of its ownK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · 3 generations on · 1 of its ownK193588 DD ContrastDental Direkt GmbH · 2020
- Descendant · 4 generations on · 1 of its ownK192251 Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070114Creation CP-ZI PorcelainJensen Industries, Inc. · 2007 · cites it directly8descendants
- K111743The Insync Ceramic SystemJensen Industries, Inc. · 2011 · 2 generations on7descendants
- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · 3 generations on3descendants
- K193588DD ContrastDental Direkt GmbH · 2020 · 3 generations on1descendant
- K192251Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002041 | Willi Geller Creation & AV Porcelain | Jensen Industries, Inc. | 2000 | — |
| 0 (this device) | K043201 | Willi Geller Creation ZI Porcelain | Jensen Industries, Inc. | 2005 | — |
| +1 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| +2 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| +3 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +3 | K193588 | DD Contrast | Dental Direkt GmbH | 2020 | — |
| +4 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 15.3 · 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? (1)
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 |
|---|---|---|---|
| * | K002041 | Willi Geller Creation & AV PorcelainSummary page 1…Dental Porcelain Classification: Class lI Product Code: EIH Predicate Devices: Willi Geller Creation& AV Porcelain: 510(k) number K002041 Lava Ceram: 510(k) number K011394* Device Description Wiliw Geller Creation Z… | 2000 |
| † | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | 2001 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070114 | Creation CP-ZI Porcelain | 2007 | 8 |
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?
Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043201: Willi Geller Creation ZI Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043201
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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