510(k) · Cleared
ClearedEpricord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Dec 22, 2003 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- Dec 22, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 3 citing it directly.
- This deviceK033267 EpricordKuraray Medical, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- Descendant · cites it directly · 11 of its ownK061860 Clearfil Majesty EstheticKuraray Medical, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K063593Clearfil Majesty FlowKuraray America, Inc. · 2007 · cites it directly17descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
- K061860Clearfil Majesty EstheticKuraray Medical, Inc. · 2006 · cites it directly11descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 2 generations on6descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033267 | Epricord | Kuraray Medical, Inc. | 2003 | — |
| +1 | K063593 | Clearfil Majesty Flow | Kuraray America, Inc. | 2007 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| +1 | K061860 | Clearfil Majesty Esthetic | Kuraray Medical, Inc. | 2006 | — |
| +2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +3 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (27)
See all 273 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, K063593 (Kuraray America, Inc., 2007) has gone furthest, with 17 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?
Epricord is indicated for the following applications:
1) Restorations using facing crowns, facing bridges, or jacket crowns.
2) Repairs of the polymer crown and bridge material or porcelain of facing crowns and jacket crowns.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033267: Epricord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033267
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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