510(k) · Cleared

Cleared

Estenia C&B

K042929510(k) TraditionalCleared Dec 6, 200445-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 Kurashiki Plant · EBF Material, Tooth Shade, Resin

Cleared on Dec 6, 2004 as substantially equivalent to K012707 (Kuraray Medical, Inc., 2001) and 10 other predicates after a 45-day review. Its family tree reaches back 7 generations to 1993. 12 later devices descend from it.

Decided: Dec 6, 2004
Review: 45 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 11

Its longest line of descent runs back 7 generations to K931812 (1993). 43 ancestors in all, the oldest K833757 (1984). 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 7 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
6 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
5 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
4 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
3 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
2 generations backK990040 Clearfil SE BondKuraray Co. · 1999
1 generation backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
This deviceK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Descendant · cites it directly · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
Descendant · cites it directly · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007high 3 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 12 · See all

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 · 2 generations on4descendants
K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · cites it directly4descendants
K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · cites it directly2descendants
K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−6	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−5	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−4	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−3	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
−2	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
−1	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
0 (this device)	K042929	Estenia C&B	Kuraray Medical Kurashiki Plant	2004	—
+1	K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	—
+2	K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value…	Kuraray Noritake Dental, Inc.	2015	—
+1	K063595	Clearfil Majesty Posterior	Kuraray America, Inc.	2007	—
+1	K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory…	Kuraray Noritake Dental, Inc.	2015	—
+2	K071169	Clearfil Majesty Posterior PLT	Kuraray Medical, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1987	1	0
1990	3	0
1991	2	0
1993	2	0
1994	6	0
1995	4	0
1996	4	0
1997	3	0
1998	3	0
1999	3	0
2001	2	0
2002	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2010	1	0
2011	1	0
2015	3	0
2017	1	0
2019	2	0
2021	1	0

FIG. 1 — Lineage of K042929, 1993–2021Source: 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

Get a 510(k) Report

What was it cleared against? (11)

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
*	K012707	Estenia	Kuraray Medical, Inc.	2001	—
*	K033267	Epricord Summary page 1 …1. ESTENIA by Kuraray Medical Inc. (KO 12707) 2. EPRICORD by Kuraray Medical Inc. (K033267) 3. CHROMVA ZONE COLOR STAIN by Kuraray Medical Inc. (1(012737) 4. SINFONY…	Kuraray Medical, Inc.	2003	—
*	K012737	Chroma Zone Color Stain Summary page 1 …2. EPRICORD by Kuraray Medical Inc. (K033267) 3. CHROMVA ZONE COLOR STAIN by Kuraray Medical Inc. (1(012737) 4. SINFONY by ESPE DENTAL AG (K992645) 5. TARGIS SYSTEM…	Kuraray Medical, Inc.	2001	—
*	K992645	Sinfony Summary page 1 …3. CHROMVA ZONE COLOR STAIN by Kuraray Medical Inc. (1(012737) 4. SINFONY by ESPE DENTAL AG (K992645) 5. TARGIS SYSTEM by IVOCLAR NORTH AMERICA, (1(962878)…	Espe Dental AG	1999	—
*	K962878	Targis System Summary page 1 …4. SINFONY by ESPE DENTAL AG (K992645) 5. TARGIS SYSTEM by IVOCLAR NORTH AMERICA, (1(962878) INC. 6. ARTGLASS & KEVLOC by HERAEUS KULZER, INC.…	Ivoclar North America, Inc.	1996	—
*	K954115	Artglass & Kevloc Summary page 1 …AMERICA, (1(962878) INC. 6. ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (1K954 115) 7. SOLIDEX by SHOFU DENTAL CORP. (K972292) 8. VENUS UNIVERSAL LIGHT…	Heraeus Kulzer, Inc.	1995	—
*	K972292	Solidex Summary page 1 …6. ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (1K954 115) 7. SOLIDEX by SHOFU DENTAL CORP. (K972292) 8. VENUS UNIVERSAL LIGHT by HERAEUS KULZER, INC. (K020131) CURING COMPOSITE…	Shofu Dental Corp.	1997	—
*	K020131	Venus Universal Light Curing Composite Summary page 1 …7. SOLIDEX by SHOFU DENTAL CORP. (K972292) 8. VENUS UNIVERSAL LIGHT by HERAEUS KULZER, INC. (K020131) CURING COMPOSITE 9. FIBREKOR by JENERIC/PENTRON, INC. (K96457s)…	Heraeus Kulzer, Inc.	2002	—
*	K964578	Fibrekor	Jeneric/Pentron, Inc.	1996	—
*	K012442	Modification to Clearfil SE Bond Summary page 1 …by JENERIC/PENTRON, INC. (K96457s) b) Other dental materials 1. CLEARFIL SE BOND by Kuraray Medical Inc. (1(012442) 2. CONNECT by SYBRON DENTAL (K954689)…	Kuraray Medical, Inc.	2001	—
*	K954689	Connect Summary page 1 …1. CLEARFIL SE BOND by Kuraray Medical Inc. (1(012442) 2. CONNECT by SYBRON DENTAL (K954689) SPECIALTIES, INC.…	Sybron Dental Specialties, Inc.	1995	—

Also cleared against K012707: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	6
K063595	Clearfil Majesty Posterior	Kuraray America, Inc.	2007	4
K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…	Kuraray Noritake Dental, Inc.	2015	2

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 11 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
None of the 43 ancestors has a recall.
Of its descendants, K111982 (Kuraray America, Inc., 2011) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K012707.

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?

ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.

1) Facing cast crowns and facing cast bridges

2) Jacket crowns

3) Inlays and onlays

4) Bridges with frameworks

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042929 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042929: Estenia C&B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042929

Report an extraction error

Are you the manufacturer?

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