510(k) · Cleared
ClearedWilli Geller Creation CP 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 Dec 20, 2004 as substantially equivalent to K024250 (Davis Schottlander & Davis, Ltd., 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003. 9 later devices descend from it.
- Decided
- Dec 20, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024250 (2003). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- This deviceK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · 2 generations on · 1 of its ownK193588 DD ContrastDental Direkt GmbH · 2020
- Descendant · 3 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 · cites it directly7descendants
- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · 2 generations on3descendants
- K193588DD ContrastDental Direkt GmbH · 2020 · 2 generations on1descendant
- K192251Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| 0 (this device) | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| +1 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| +1 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| +2 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +2 | K193588 | DD Contrast | Dental Direkt GmbH | 2020 | — |
| +3 | 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 15.2 · 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 |
|---|---|---|---|
| * | K024250 | Match Press Pressable CeramicSummary page 1…Dental Porcelain Classification: Class II Product Code: EIH Predicate Device: Match Press pressable ceramic: 510(k) number K024250 Device Description WilEl Geller CreationCP porcelain consists of pressable ceramic pellets that are used by dental technicians… | 2003 |
What descends from it? (9)
2 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, K070114 (Jensen Industries, Inc., 2007) has gone furthest, with 8 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?
Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing dental porcelains such as Willi Geller Creation (K981490) or Willi Geller Creation & LF (K02904).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043221: Willi Geller Creation CP Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043221
Report an extraction error
Are you the manufacturer?
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