510(k) · Cleared
Clearedzirkon; structure; LFU shades, stains and glazes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Estetic Ceram AG · EIH Powder, Porcelain
Cleared on Jun 5, 2025 as substantially equivalent to K192251 (Cendres+Metaux SA, 2020) after a 57-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Jun 5, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K024250 (2003). 13 ancestors in all, the oldest K830955 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- 5 generations backK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- 4 generations backK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- 3 generations backK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- 2 generations backK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- 1 generation backK192251 Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020
- This deviceK251084 zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| −5 | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| −4 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| −3 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| −2 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| −1 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020 | — |
| 0 (this device) | K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K192251 | Livento Press, Soprano 10, Soprano Our reading of the summary gave K192551, FDA’s number for 1ml Luer Slip or Luer Lock Syringe, Syringe with… (Jiangsu Caina Medical Co.,Ltd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Soprano 10, Soprano surface and Soprano”. | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
Types of restorations:
1. Anterior and posterior crowns
2. Veneers, inlays, onlays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251084: zirkon; structure; LFU shades, stains and glazes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251084
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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