510(k) · Cleared
ClearedClearfil Photo Core
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Co. · EBF Material, Tooth Shade, Resin
Cleared on Jun 13, 1988 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 13, 1988
- Review
- 31 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK882006 Clearfil Photo CoreKuraray Co. · 1988
- Descendant · cites it directly · 1 of its ownK012705 Clearfil Photo CoreKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK113617 Spee-Dee PatchPulpdent Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK033970 Clearfil Photo Core PLTKuraray Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK993488 Light-CoreBisco, Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K012705Clearfil Photo CoreKuraray Medical, Inc. · 2001 · cites it directly1descendant
- K113617Spee-Dee PatchPulpdent Corporation · 2012 · cites it directly0descendants
- K033970Clearfil Photo Core PLTKuraray Medical, Inc. · 2004 · 2 generations on0descendants
- K993488Light-CoreBisco, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882006 | Clearfil Photo Core | Kuraray Co. | 1988 | — |
| +1 | K012705 | Clearfil Photo Core | Kuraray Medical, Inc. | 2001 | — |
| +1 | K113617 | Spee-Dee Patch | Pulpdent Corporation | 2012 | — |
| +2 | K033970 | Clearfil Photo Core PLT | Kuraray Medical, Inc. | 2004 | — |
| +1 | K993488 | Light-Core | Bisco, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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, K012705 (Kuraray Medical, Inc., 2001) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K882006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882006: Clearfil Photo Core.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026