510(k) · Cleared
ClearedSolidex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shofu Dental Corp. · EBF Material, Tooth Shade, Resin
Cleared on Oct 29, 1997 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 22 later devices descend from it.
- Decided
- Oct 29, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 3 citing it directly.
- This deviceK972292 SolidexShofu Dental Corp. · 1997
- Descendant · cites it directly · 18 of its ownK982164 EsteniaKuraray America, Inc. · 1998
- Descendant · 2 generations on · 17 of its ownK012707 EsteniaKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 15 of its ownK982259 Chroma Zone Color StainKuraray America, Inc. · 1998
- Descendant · 2 generations on · 14 of its ownK012737 Chroma Zone Color StainKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K982164EsteniaKuraray America, Inc. · 1998 · cites it directly18descendants
- K012707EsteniaKuraray Medical, Inc. · 2001 · 2 generations on17descendants
- K982259Chroma Zone Color StainKuraray America, Inc. · 1998 · cites it directly15descendants
- K012737Chroma Zone Color StainKuraray Medical, Inc. · 2001 · 2 generations on14descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972292 | Solidex | Shofu Dental Corp. | 1997 | — |
| +1 | K982164 | Estenia | Kuraray America, Inc. | 1998 | — |
| +2 | K012707 | Estenia | Kuraray Medical, Inc. | 2001 | — |
| +1 | K982259 | Chroma Zone Color Stain | Kuraray America, Inc. | 1998 | — |
| +2 | K012737 | Chroma Zone Color Stain | Kuraray Medical, Inc. | 2001 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (22)
See all 223 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, K982164 (Kuraray America, Inc., 1998) has gone furthest, with 18 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequate framework.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972292: Solidex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972292
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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