510(k) · Cleared

Cleared

Clearfil ST Opaquer

K001913510(k) TraditionalCleared Aug 4, 200042-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 Company, Ltd. · EBF Material, Tooth Shade, Resin

Cleared on Aug 4, 2000 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Aug 4, 2000
Review: 42 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

7 later devices descend from it, 2 citing it directly.

This deviceK001913 Clearfil ST OpaquerKuraray Company, Ltd. · 2000
Descendant · cites it directly · 5 of its ownK012704 Clearfil ST OpaquerKuraray Medical, Inc. · 2001
Descendant · 2 generations on · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
Descendant · 3 generations on · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
Descendant · 3 generations on · 0 of its ownK162967 nuance UNIVERSALDen-Mat Holdings, LLC · 2017
Descendant · 3 generations on · 0 of its ownK100328 Clearfil Majety PosteriorKuraray Medical, Inc. · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2001high 2 (2007) · low 0 (2002)2026

Most influential descendants

Showing 5 of 7 · See all

K012704Clearfil ST OpaquerKuraray Medical, Inc. · 2001 · cites it directly5descendants
K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · 2 generations on4descendants
K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · 3 generations on1descendant
K162967nuance UNIVERSALDen-Mat Holdings, LLC · 2017 · 3 generations on0descendants
K100328Clearfil Majety PosteriorKuraray Medical, Inc. · 2010 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001913	Clearfil ST Opaquer	Kuraray Company, Ltd.	2000	—
+1	K012704	Clearfil ST Opaquer	Kuraray Medical, Inc.	2001	—
+2	K063595	Clearfil Majesty Posterior	Kuraray America, Inc.	2007	—
+3	K071169	Clearfil Majesty Posterior PLT	Kuraray Medical, Inc.	2007	—
+3	K162967	nuance UNIVERSAL	Den-Mat Holdings, LLC	2017	—
+3	K100328	Clearfil Majety Posterior	Kuraray Medical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2007	2	0
2009	2	0
2010	1	0
2017	1	0

FIG. 1 — Lineage of K001913, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (7)

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

Number	Device	Applicant	Decided	Descendants
K012704	Clearfil ST Opaquer	Kuraray Medical, Inc.	2001	5
K090843	Amaris Gingiva Opaquer	Voco GmbH	2009	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?

Of its descendants, K012704 (Kuraray Medical, Inc., 2001) has gone furthest, with 5 descendants of its own.

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	—

https://510kreport.com/device/K001913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001913: Clearfil ST Opaquer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001913

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026