510(k) · Cleared

Cleared

Clearfil AP-X

K012740510(k) TraditionalCleared Sep 14, 200131-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuraray Medical, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Sep 14, 2001 as substantially equivalent to K943168 (Kuraray Company, Ltd., 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. 35 later devices descend from it.

Decided: Sep 14, 2001
Review: 31 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K943168 (1994). 35 later devices descend from it, 11 citing it directly.

By dateBy generation

Root · 1 generation backK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
This deviceK012740 Clearfil AP-XKuraray Medical, Inc. · 2001
Descendant · cites it directly · 17 of its ownK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007
Descendant · cites it directly · 11 of its ownK061860 Clearfil Majesty EstheticKuraray Medical, Inc. · 2006
Descendant · cites it directly · 9 of its ownK023002 Clearfil AP-X PLTKuraray Medical, Inc. · 2002
Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
Descendant · cites it directly · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2002high 4 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 35 · See all

K063593Clearfil Majesty FlowKuraray America, Inc. · 2007 · cites it directly17descendants
K061860Clearfil Majesty EstheticKuraray Medical, Inc. · 2006 · cites it directly11descendants
K023002Clearfil AP-X PLTKuraray Medical, Inc. · 2002 · cites it directly9descendants
K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · cites it directly6descendants
K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943168	Clearfil AP-X	Kuraray Company, Ltd.	1994	—
0 (this device)	K012740	Clearfil AP-X	Kuraray Medical, Inc.	2001	—
+1	K063593	Clearfil Majesty Flow	Kuraray America, Inc.	2007	—
+1	K061860	Clearfil Majesty Esthetic	Kuraray Medical, Inc.	2006	—
+1	K023002	Clearfil AP-X PLT	Kuraray Medical, Inc.	2002	—
+1	K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	—
+1	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
2002	2	0
2004	2	0
2006	1	0
2007	4	0
2009	1	0
2010	1	0
2011	3	0
2012	1	0
2013	4	0
2015	3	0
2017	2	0
2019	4	0
2020	2	0
2021	3	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K012740, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K943168	Clearfil AP-X Summary page 1 …submission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL AP-X by Kuraray Co., Ltd. (K943168) 4. Description for the premarket notification This product is classified into Tooth shade Resin Material, CFR 29 Section 872.36…	Kuraray Company, Ltd.	1994	—

Also cleared against K943168: 2 other devices →

What descends from it? (35)

See all 35

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063593	Clearfil Majesty Flow	Kuraray America, Inc.	2007	17
K061860	Clearfil Majesty Esthetic	Kuraray Medical, Inc.	2006	11
K023002	Clearfil AP-X PLT	Kuraray Medical, Inc.	2002	9
K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	6
K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…	Kuraray Noritake Dental, Inc.	2015	4
K063595	Clearfil Majesty Posterior	Kuraray America, Inc.	2007	4
K042124	Denfil	Vericom Co., Ltd.	2004	4
K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…	Kuraray Noritake Dental, Inc.	2015	2
K142623	PANAVIA SA Cement Plus Handmix	Kuraray Noritake Dental, Inc.	2015	0
K133078	K-Etchant Syringe; Needle Tip (E)	Kuraray Noritake Dental, Inc.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K063593 (Kuraray America, Inc., 2007) has gone furthest, with 17 descendants of its own.
2 other devices also cite its predicate K943168.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012740 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012740: Clearfil AP-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012740

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026