510(k) · Cleared
ClearedClearfil AP-X PLT
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 Oct 25, 2002 as substantially equivalent to K012740 (Kuraray Medical, Inc., 2001) after a 46-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 46 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943168 (1994). 9 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
- 1 generation backK012740 Clearfil AP-XKuraray Medical, Inc. · 2001
- This deviceK023002 Clearfil AP-X PLTKuraray Medical, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK042124 DenfilVericom Co., Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK192510 DIAFIL & DIAFIL CapsuleDiaDent Group International · 2020
- Descendant · cites it directly · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK261093 DiafilDiaDent Group International · 2026
- Descendant · 3 generations on · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K042124DenfilVericom Co., Ltd. · 2004 · cites it directly4descendants
- K192510DIAFIL & DIAFIL CapsuleDiaDent Group International · 2020 · 2 generations on2descendants
- K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · cites it directly1descendant
- K261093DiafilDiaDent Group International · 2026 · 3 generations on0descendants
- K210421Diafil & Diafil CapsuleDiaDent Group International · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943168 | Clearfil AP-X | Kuraray Company, Ltd. | 1994 | — |
| −1 | K012740 | Clearfil AP-X | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K023002 | Clearfil AP-X PLT | Kuraray Medical, Inc. | 2002 | — |
| +1 | K042124 | Denfil | Vericom Co., Ltd. | 2004 | — |
| +2 | K192510 | DIAFIL & DIAFIL Capsule | DiaDent Group International | 2020 | — |
| +1 | K071169 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2007 | — |
| +3 | K261093 | Diafil | DiaDent Group International | 2026 | — |
| +3 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012740 | Clearfil AP-X | 2001 |
What descends from it? (9)
4 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042124 (Vericom Co., Ltd., 2004) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K012740.
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 AP-X PLT is indicated for the following applications:
1) Class I, II, V restorations of posterior teeth
2) Class III, IV, V restorations of anterior teeth
3) Cervical cavities or defects involving root surfaces
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023002: Clearfil AP-X PLT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023002
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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