510(k) · Cleared
ClearedWilli Geller Ceramic Creation & Surprise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creation North America, Inc. · EIH Powder, Porcelain
Cleared on Apr 9, 1990 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 9, 1990
- Review
- 82 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK900209 Willi Geller Ceramic Creation & SurpriseCreation North America, Inc. · 1990
- Descendant · cites it directly · 6 of its ownK981490 Willi Geller Creation PorcelainJensen Industries, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK140848 Luminesse Porcelain SystemTalladium, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK182350 Dental CeramicBaot Biological Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK163251 Life Essence Universal Porcelain SystemBlue Sky Bio · 2017
- Descendant · 2 generations on · 0 of its ownK063842 Cyrtina SystemOratio B.V. · 2007
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981490Willi Geller Creation PorcelainJensen Industries, Inc. · 1998 · cites it directly6descendants
- K140848Luminesse Porcelain SystemTalladium, Inc. · 2014 · 2 generations on2descendants
- K182350Dental CeramicBaot Biological Technology Co., Ltd. · 2019 · 3 generations on0descendants
- K163251Life Essence Universal Porcelain SystemBlue Sky Bio · 2017 · 3 generations on0descendants
- K063842Cyrtina SystemOratio B.V. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900209 | Willi Geller Ceramic Creation & Surprise | Creation North America, Inc. | 1990 | — |
| +1 | K981490 | Willi Geller Creation Porcelain | Jensen Industries, Inc. | 1998 | — |
| +2 | K140848 | Luminesse Porcelain System | Talladium, Inc. | 2014 | — |
| +3 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | 2019 | — |
| +3 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | 2017 | — |
| +2 | K063842 | Cyrtina System | Oratio B.V. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981490 | Willi Geller Creation Porcelain | 1998 | 6 |
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, K981490 (Jensen Industries, Inc., 1998) has gone furthest, with 6 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/K900209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900209: Willi Geller Ceramic Creation & Surprise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900209
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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