510(k) · Cleared
ClearedCleafil DC Core Automix
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 17, 2004 after a 31-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK043177 Cleafil DC Core AutomixKuraray Medical, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006 · cites it directly10descendants
- K081583Clearfil SA CementKuraray Medical, Inc. · 2008 · 2 generations on9descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · cites it directly6descendants
- K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · 3 generations on5descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043177 | Cleafil DC Core Automix | Kuraray Medical, Inc. | 2004 | — |
| +1 | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +2 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| +1 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +3 | K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 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? (13)
See all 133 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, K062410 (Kuraray Medical, Inc., 2006) has gone furthest, with 10 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?
CLEARFIL DC CORE AUTOMIX is indicated for the following application:
1) Core build-up of vital or non-vital tooth
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043177: Cleafil DC Core Automix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043177
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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