510(k) · Cleared
ClearedWilli Geller Creation 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 Oct 22, 1998 as substantially equivalent to K900209 (Creation North America, Inc., 1990) after a 178-day review. Its family tree reaches back 1 generation to 1990. 6 later devices descend from it.
- Decided
- Oct 22, 1998
- Review
- 178 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900209 (1990). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK900209 Willi Geller Ceramic Creation & SurpriseCreation North America, Inc. · 1990
- This deviceK981490 Willi Geller Creation PorcelainJensen Industries, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK140848 Luminesse Porcelain SystemTalladium, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK182350 Dental CeramicBaot Biological Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK163251 Life Essence Universal Porcelain SystemBlue Sky Bio · 2017
- Descendant · cites it directly · 0 of its ownK063842 Cyrtina SystemOratio B.V. · 2007
- Descendant · cites it directly · 0 of its ownK042638 Radiance PorcelainAurident, Inc. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140848Luminesse Porcelain SystemTalladium, Inc. · 2014 · cites it directly2descendants
- K182350Dental CeramicBaot Biological Technology Co., Ltd. · 2019 · 2 generations on0descendants
- K163251Life Essence Universal Porcelain SystemBlue Sky Bio · 2017 · 2 generations on0descendants
- K063842Cyrtina SystemOratio B.V. · 2007 · cites it directly0descendants
- K042638Radiance PorcelainAurident, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900209 | Willi Geller Ceramic Creation & Surprise | Creation North America, Inc. | 1990 | — |
| 0 (this device) | K981490 | Willi Geller Creation Porcelain | Jensen Industries, Inc. | 1998 | — |
| +1 | K140848 | Luminesse Porcelain System | Talladium, Inc. | 2014 | — |
| +2 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | 2019 | — |
| +2 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | 2017 | — |
| +1 | K063842 | Cyrtina System | Oratio B.V. | 2007 | — |
| +1 | K042638 | Radiance Porcelain | Aurident, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K900209 | Willi Geller Ceramic Creation & SurpriseSummary page 1…sed to metal crowns and bridges, laminate veneers, and inlays. The product is substantially equivalent to the Willi Geller Creation ceramic which was cleared via 510(k) #K900209. The ceramic powders in the Creation porcelain system are composed in varying proportions of silicon dioxide, aluminum oxide, so… | 1990 |
What descends from it? (6)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K140848 (Talladium, Inc., 2014) has gone furthest, with 2 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?
The product is intended for use in fabricating oral
crowns and bridges and laminate veneers and inlays for
dental use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981490 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981490: Willi Geller Creation Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981490
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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