510(k) · Cleared
ClearedWilli Geller Creation & AV 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 Aug 16, 2000 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 16, 2000
- Review
- 42 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK002041 Willi Geller Creation & AV PorcelainJensen Industries, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK043201 Willi Geller Creation ZI PorcelainJensen Industries, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- Descendant · 3 generations on · 7 of its ownK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- Descendant · 4 generations on · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · 4 generations on · 1 of its ownK193588 DD ContrastDental Direkt GmbH · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K043201Willi Geller Creation ZI PorcelainJensen Industries, Inc. · 2005 · cites it directly9descendants
- K070114Creation CP-ZI PorcelainJensen Industries, Inc. · 2007 · 2 generations on8descendants
- K111743The Insync Ceramic SystemJensen Industries, Inc. · 2011 · 3 generations on7descendants
- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · 4 generations on3descendants
- K193588DD ContrastDental Direkt GmbH · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002041 | Willi Geller Creation & AV Porcelain | Jensen Industries, Inc. | 2000 | — |
| +1 | K043201 | Willi Geller Creation ZI Porcelain | Jensen Industries, Inc. | 2005 | — |
| +2 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| +3 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| +4 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +4 | K193588 | DD Contrast | Dental Direkt GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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), 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? (11)
See all 112 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, K043201 (Jensen Industries, Inc., 2005) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K002041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002041: Willi Geller Creation & AV Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002041
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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