510(k) · Cleared

Cleared

Clearfil AP-X

K943168510(k) TraditionalCleared Aug 10, 199440-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 10, 1994 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 130 later devices descend from it.

Decided: Aug 10, 1994
Review: 40 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

130 later devices descend from it, 3 citing it directly.

This deviceK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
Descendant · cites it directly · 93 of its ownK984201 DenzirDentronic AB · 1999
Descendant · 2 generations on · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
Descendant · 2 generations on · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
Descendant · 2 generations on · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
Descendant · 3 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

1999high 10 (2015) · low 0 (2000)2026

Most influential descendants

Showing 5 of 130 · See all

K984201DenzirDentronic AB · 1999 · cites it directly93descendants
K023327Cynovad ZirkonCynovad · 2002 · 2 generations on91descendants
K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · 2 generations on80descendants
K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · 2 generations on76descendants
K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 3 generations on43descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943168	Clearfil AP-X	Kuraray Company, Ltd.	1994	—
+1	K984201	Denzir	Dentronic AB	1999	—
+2	K023327	Cynovad Zirkon	Cynovad	2002	—
+2	K043472	Medin Tech Zirconia-CP10, SS1000	Medin Tech	2005	—
+2	K062695	Sagemax Z-Blank	Sagemax Bioceramics, Inc.	2006	—
+3	K081850	Bisque Zirconia Blanks, Type Byz	Zircar Zirconia, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	3	0
2004	4	0
2005	1	0
2006	2	0
2007	7	0
2008	5	0
2009	5	0
2010	5	0
2011	6	0
2012	4	0
2013	6	0
2014	6	0
2015	10	0
2016	3	0
2017	3	0
2018	3	0
2019	6	0
2020	7	0
2021	10	0
2022	8	0
2023	7	0
2024	9	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K943168, 1994–2026Source: 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

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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? (130)

See all 130

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

Number	Device	Applicant	Decided	Descendants
K984201	Denzir	Dentronic AB	1999	93
K012740	Clearfil AP-X	Kuraray Medical, Inc.	2001	35
K042548	Cerasys - ZR	Cerasys, Inc.	2004	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, K984201 (Dentronic AB, 1999) has gone furthest, with 93 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/K943168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943168: Clearfil AP-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943168

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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