510(k) · Cleared
ClearedGradia Direct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jan 30, 2003 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Jan 30, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK023814 Gradia DirectGC America, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK061860 Clearfil Majesty EstheticKuraray Medical, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK121583 Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK192178 R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K061860Clearfil Majesty EstheticKuraray Medical, Inc. · 2006 · cites it directly11descendants
- K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · 2 generations on4descendants
- K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012 · 2 generations on3descendants
- K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · 3 generations on1descendant
- K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023814 | Gradia Direct | GC America, Inc. | 2003 | — |
| +1 | K061860 | Clearfil Majesty Esthetic | Kuraray Medical, Inc. | 2006 | — |
| +2 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +2 | K121583 | Clearfil Majesty Flow | Kuraray Noritake Dental, Inc. | 2012 | — |
| +3 | K071169 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2007 | — |
| +2 | K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061860 | Clearfil Majesty Esthetic | 2006 | 11 |
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, K061860 (Kuraray Medical, Inc., 2006) has gone furthest, with 11 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?
GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:
GRADIA DIRECT ANTERIOR:
1. Direct restorative for Class III, IV and V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.
GRADIA DIRECT POSTERIOR:
1. Direct restorations for Class I and II cavities.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023814: Gradia Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023814
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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