510(k) · Cleared

Cleared

Clearfil SE Bond

K990040510(k) TraditionalCleared Feb 4, 199929-day reviewClass II21 CFR 872.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuraray Co. · KLE Agent, Tooth Bonding, Resin

Cleared on Feb 4, 1999 as substantially equivalent to K974486 (Kuraray America, Inc., 1998) and 6 other predicates after a 29-day review. Its family tree reaches back 5 generations to 1993. 64 later devices descend from it.

Decided: Feb 4, 1999
Review: 29 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 7

Its longest line of descent runs back 5 generations to K931812 (1993). 15 ancestors in all, the oldest K871636 (1987). 64 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 5 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
4 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
3 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
2 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
1 generation backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
This deviceK990040 Clearfil SE BondKuraray Co. · 1999
Descendant · cites it directly · 60 of its ownK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
Descendant · 2 generations on · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
Descendant · 3 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
Descendant · 3 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
Descendant · 2 generations on · 17 of its ownK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2001high 7 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 64 · See all

K012442Modification to Clearfil SE BondKuraray Medical, Inc. · 2001 · cites it directly60descendants
K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · 2 generations on34descendants
K094007Unicem3M Espe AG Dental Products · 2010 · 3 generations on22descendants
K100756MALTA3M Espe AG Dental Products · 2010 · 3 generations on19descendants
K063593Clearfil Majesty FlowKuraray America, Inc. · 2007 · 2 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−4	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−3	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−2	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−1	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
0 (this device)	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
+1	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
+2	K032455	Panavia F 2.0	Kuraray Medical, Inc.	2003	—
+3	K094007	Unicem	3M Espe AG Dental Products	2010	—
+3	K100756	MALTA	3M Espe AG Dental Products	2010	—
+2	K063593	Clearfil Majesty Flow	Kuraray America, Inc.	2007	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	3	0
2004	2	0
2006	4	0
2007	4	0
2008	2	0
2009	3	0
2010	4	0
2011	4	0
2012	3	0
2013	6	0
2015	3	0
2016	2	0
2017	2	0
2018	2	0
2019	7	0
2020	1	0
2021	2	0
2023	1	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K990040, 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 KLE? 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 KLE device

#1 K262252 MPa Max adhesivescore 15.1 · 11 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? (8)

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
*	K974486	Clearfil Liner Bond 2V Summary page 1 …Resin tooth bonding agent (21CFR 872.3200) 3) Common/Usual Name Resin-based dental adhesive system 4. Predicate devices: 1. CLEARFIL LINER BOND 2V by KURARAY CO.,LTD. (K974486) 2. CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. (K943170) 3. CLEARFIL PHOTO BOND by KURARAY CO.,LTD. (K943165) 4. PRIME & BOND 2…	Kuraray America, Inc.	1998	—
*	K943170	Clearfil Liner Bond 2 Summary page 1 …al Name Resin-based dental adhesive system 4. Predicate devices: 1. CLEARFIL LINER BOND 2V by KURARAY CO.,LTD. (K974486) 2. CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. (K943170) 3. CLEARFIL PHOTO BOND by KURARAY CO.,LTD. (K943165) 4. PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WI…	Kuraray Company, Ltd.	1994	—
*	K943165	Clearfil Photo Bond Summary page 1 …te devices: 1. CLEARFIL LINER BOND 2V by KURARAY CO.,LTD. (K974486) 2. CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. (K943170) 3. CLEARFIL PHOTO BOND by KURARAY CO.,LTD. (K943165) 4. PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY . GLUMA ONE BOND by HERAEUS…	Kuraray Company, Ltd.	1994	—
*	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator Summary page 1 …(K974486) 2. CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. (K943170) 3. CLEARFIL PHOTO BOND by KURARAY CO.,LTD. (K943165) 4. PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY . GLUMA ONE BOND by HERAEUS KULZER, INC. (K974390) 6. ONE STEP UNIVERSAL DENTAL ADHES…	Dentsply Intl.	1997	—
*	K974390	Gluma One Bond Summary page 1 …KURARAY CO.,LTD. (K943165) 4. PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY . GLUMA ONE BOND by HERAEUS KULZER, INC. (K974390) 6. ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by BISCO, (K#unknown) INC. 7. ALL-BOND 2 by BISCO, INC. (K910860) 8. OPTIBOND by…	Heraeus Kulzer, Inc.	1998	—
*	K910860	All-Bond 2 Summary page 1 …R by DENTSPLY . GLUMA ONE BOND by HERAEUS KULZER, INC. (K974390) 6. ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by BISCO, (K#unknown) INC. 7. ALL-BOND 2 by BISCO, INC. (K910860) 8. OPTIBOND by KERR MFG.CO (K934690) 5. Description for the premarket notification CLEARFIL SE BOND is classified into the res…	Bisco, Inc.	1991	—
*	K934690	Kerr Optibond, Modification Summary page 1 …AEUS KULZER, INC. (K974390) 6. ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by BISCO, (K#unknown) INC. 7. ALL-BOND 2 by BISCO, INC. (K910860) 8. OPTIBOND by KERR MFG.CO (K934690) 5. Description for the premarket notification CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section…	Kerr Corporation (Danbury)	1993	—
*	—	One Step Universal Dental Adhesive System Named without a submission number			—
†	K983361	Panavia F	Kuraray America, Inc.	1998	—
†	K982164	Estenia	Kuraray America, Inc.	1998	—

Also cleared against K974486: 1 other device →

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	60
K070956	SEA2 Self Etch Adhesive	3M Espe Dental Products	2007	0
K063558	Peak SE, Model 5135	Ultradent Products, Inc.	2006	0
K040952	Prelude	Danville Materials, Inc.	2004	0
K013519	Simple	Bisco, Inc.	2002	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 6 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K012442 (Kuraray Medical, Inc., 2001) has gone furthest, with 60 descendants of its own.
1 other device also cites its predicate K974486.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, 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	14	71	2	18
2008	3	66	0	9
2009	7	79	1	11
2010	8	93	1	13
2011	10	100	0	69
2012	5	66	0	176
2013	11	115	0	248
2014	6	120	0	260
2015	10	118	0	100
2016	3	148	1	47
2017	4	171	1	42
2018	8	124	0	31
2019	6	143	0	20
2020	6	195	0	6
2021	4	163	0	6
2022	8	98	0	7
2023	6	75	0	7
2024	7	61	1	12
2025	3	149	0	3
2026	7	84	0	—

What is it indicated for?

CLEARFIL SE BOND is indicated for the following applications:

1) Direct filling restorations using light-curing composite or compomer

2) Cavity sealing as a pretreatment for indirect restorations

3) Treatment of hypersensitive and/or exposed root surfaces

4) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin

5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990040 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990040: Clearfil SE Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990040

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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