510(k) · Cleared

Cleared

Clearfil Ceramic Primer

K061906510(k) TraditionalCleared Sep 28, 200685-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 28, 2006 as substantially equivalent to K012730 (Kuraray Medical, Inc., 2001) and 3 other predicates after an 85-day review. Its family tree reaches back 7 generations to 1993. 9 later devices descend from it.

Decided: Sep 28, 2006
Review: 85 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K931812 (1993). 21 ancestors in all, the oldest K871636 (1987). 9 later devices descend from it, 4 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 deviceK061906 Clearfil Ceramic PrimerKuraray Medical, Inc. · 2006
Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
Descendant · 2 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
Descendant · cites it directly · 1 of its ownK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
Descendant · cites it directly · 1 of its ownK091705 Primer PlusBisco, Inc. · 2009
Descendant · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all

K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
K171449MetacemMeta Biomed Co., Ltd. · 2018 · 2 generations on1descendant
K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc. · 2013 · cites it directly1descendant
K091705Primer PlusBisco, Inc. · 2009 · cites it directly1descendant
K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants

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)	K061906	Clearfil Ceramic Primer	Kuraray Medical, Inc.	2006	—
+1	K081913	Metacem, Meta P&Bond, Metacem Silane Ceramic Primer	Meta Biomed Co., Ltd.	2008	—
+2	K171449	Metacem	Meta Biomed Co., Ltd.	2018	—
+1	K132450	Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil…	Kuraray Noritake Dental, Inc.	2013	—
+1	K091705	Primer Plus	Bisco, Inc.	2009	—
+3	K261166	Dia-Cem	DiaDent Group International	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1990	1	0
1991	1	0
1993	2	0
1994	5	0
1995	1	0
1998	1	0
2001	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	2	0
2013	2	0
2018	2	0
2021	1	0
2026	1	0

FIG. 1 — Lineage of K061906, 1993–2026Source: 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? (4)

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
*	K012730	Clearfil Porcelain Bond Activator Summary page 1 …00. Product code: KLE) 3) Common name Silane c'upling agent 3-3. Predicate device 1) CLEARFIL PORCELAIN 510(k) liumber: K012730 BOND ACTIVATOR Product Code: KLE 21 CFR Section: 872…	Kuraray Medical, Inc.	2001	—
*	K012442	Modification to Clearfil SE Bond Summary page 1 …CFR Section: 872.3200 Applici Nit: KURARAY MEDICAL INC. 2) CLEARFIL SE BOND 510(k) Number: K012442 Produe Code: KLE 21 CFR Section: 872…	Kuraray Medical, Inc.	2001	—
*	K042913	Clearfil Tri-S Bond Summary page 1 …FR Section: 872.3200 Applicanat: KURARAY AMERICA, INC. 3) CLEARFILTRI-S BOND 510(k) Number: K042913 Product Code: KLE 21 CFU Section: 872…	Kuraray Medical, Inc.	2004	—
*	K905220	Monobond S Summary page 1 …FU Section: 872.3200 Applic: rt: KURARAY COMPANY, LTD. 4) MONOBOND S 510(k) Number: K905220 Product Code: EBF 21 CFU: Section: 872…	Ivoclar North America, Inc.	1990	—

Also cleared against K012730: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K081913	Metacem, Meta P&Bond, Metacem Silane Ceramic Primer	Meta Biomed Co., Ltd.	2008	3
K132450	Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…	Kuraray Noritake Dental, Inc.	2013	1
K091705	Primer Plus	Bisco, Inc.	2009	1
K091300	Ascent Porcelain Primer, Model 006-00078, 00600079	CAO Group, Inc.	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?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
None of the 21 ancestors has a recall.
Of its descendants, K081913 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K012730.

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?

1) Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin

2) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061906: Clearfil Ceramic Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061906

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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