510(k) · Cleared

Cleared

Clearfil DC Core Plus

K111982510(k) TraditionalCleared Nov 17, 2011128-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 America, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Nov 17, 2011 as substantially equivalent to K043177 (Kuraray Medical, Inc., 2004) and 5 other predicates after a 128-day review. Its family tree reaches back 10 generations to 1993. 6 later devices descend from it.

Decided: Nov 17, 2011
Review: 128 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 6

Its longest line of descent runs back 10 generations to K931812 (1993). 56 ancestors in all, the oldest K833757 (1984). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
6 generations between
3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
2 generations backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
1 generation backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
This deviceK111982 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
Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Descendant · 3 generations on · 0 of its ownK210504 PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021
Descendant · 3 generations on · 0 of its ownK191524 Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019
Descendant · 2 generations on · 0 of its ownK183537 PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc. · 2019

Show all 10 generations

Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
9 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
8 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
7 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
6 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
5 generations backK990040 Clearfil SE BondKuraray Co. · 1999
4 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
2 generations backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
1 generation backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
This deviceK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2015high 3 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all

K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · cites it directly4descendants
K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021 · 3 generations on0descendants
K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019 · 3 generations on0descendants
K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−10	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−9	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−8	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−7	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−6	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
−5	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
−4	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
−3	K032455	Panavia F 2.0	Kuraray Medical, Inc.	2003	—
−2	K062410	Clearfil Esthetic Cement & DC Bond	Kuraray Medical, Inc.	2006	—
−1	K081583	Clearfil SA Cement	Kuraray Medical, Inc.	2008	—
0 (this device)	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	—
+2	K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory…	Kuraray Noritake Dental, Inc.	2015	—
+3	K210504	PANAVIA Veneer LC	Kuraray Noritake Dental, Inc.	2021	—
+3	K191524	Visalys Tooth Primer	Kettenbach GmbH & Co. KG	2019	—
+2	K183537	PANAVIA SA Cement Universal	Kuraray Noritake Dental, Inc.	2019	—

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	7	0
1995	4	0
1996	4	0
1997	3	0
1998	4	0
1999	4	0
2001	5	0
2002	1	0
2003	1	0
2004	3	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	3	0
2019	2	0
2021	1	0

FIG. 1 — Lineage of K111982, 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? (6)

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
*	K043177	Cleafil DC Core Automix Summary page 1 …CORE AUTOMIX 510(k) Number: K043177 Product Code:…	Kuraray Medical, Inc.	2004	—
*	K081583	Clearfil SA Cement	Kuraray Medical, Inc.	2008	—
*	K062410	Clearfil Esthetic Cement & DC Bond Summary page 1 …INC. 51I0(k) Number: K(062410 Product Code:…	Kuraray Medical, Inc.	2006	—
*	K063593	Clearfil Majesty Flow Summary page 1 …ICAL Flow 5 10(k) Number: INC. K(063593 Product Code:…	Kuraray America, Inc.	2007	—
*	K012740	Clearfil AP-X Summary page 1 …INC. 51 0(k) Number: K0127 4 0 Product Code:…	Kuraray Medical, Inc.	2001	—
*	K042929	Estenia C&B Summary page 1 …INC. 5 10(k) Number: K042929 Product Code: EI3…	Kuraray Medical Kurashiki Plant	2004	—

Also cleared against K043177: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…	Kuraray Noritake Dental, Inc.	2015	4
K142623	PANAVIA SA Cement Plus Handmix	Kuraray Noritake Dental, Inc.	2015	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?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
None of the 56 ancestors has a recall.
Of its descendants, K142625 (Kuraray Noritake Dental, Inc., 2015) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K043177.

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. 2011, this device’s year, is highlighted.

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?

Post cementation and core build-up

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111982 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111982: Clearfil DC Core Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111982

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