510(k) · Cleared

Cleared

Clearfil Liner Bond 2V

K974486510(k) TraditionalCleared Jan 29, 199864-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 America, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Jan 29, 1998 as substantially equivalent to K943170 (Kuraray Company, Ltd., 1994) and 7 other predicates after a 64-day review. Its family tree reaches back 4 generations to 1993. 67 later devices descend from it.

Decided: Jan 29, 1998
Review: 64 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 8

Its longest line of descent runs back 4 generations to K931812 (1993). 13 ancestors in all, the oldest K871636 (1987). 67 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
3 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
2 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
1 generation backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
This deviceK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
Descendant · cites it directly · 64 of its ownK990040 Clearfil SE BondKuraray Co. · 1999
Descendant · 2 generations on · 60 of its ownK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
Descendant · 3 generations on · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
Descendant · 4 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
Descendant · 4 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1999high 7 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 67 · See all

K990040Clearfil SE BondKuraray Co. · 1999 · cites it directly64descendants
K012442Modification to Clearfil SE BondKuraray Medical, Inc. · 2001 · 2 generations on60descendants
K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · 3 generations on34descendants
K094007Unicem3M Espe AG Dental Products · 2010 · 4 generations on22descendants
K100756MALTA3M Espe AG Dental Products · 2010 · 4 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

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

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0
2002	2	0
2003	3	0
2004	2	0
2006	5	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 K974486, 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? (9)

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
*	K943170	Clearfil Liner Bond 2 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 2 by Kuraray Co., Ltd. (K943170) 2) CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. (K871636) 3) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. (K943165) 4) CLEARFIL N…	Kuraray Company, Ltd.	1994	—
*	K871636	Clearfil Porcelain Bond Summary page 1 …Name Resin-based dental adhesive system 4. Predicate devices: 1) CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. (K943170) 2) CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. (K871636) 3) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. (K943165) 4) CLEARFIL NEW BOND by Kuraray Co., Ltd. (K943167) 5) SCOTCHBOND MULTI…	Kuraray Co.	1987	—
*	K943165	Clearfil Photo Bond Summary page 1 …evices: 1) CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. (K943170) 2) CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. (K871636) 3) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. (K943165) 4) CLEARFIL NEW BOND by Kuraray Co., Ltd. (K943167) 5) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE (K942493) SYSTEM by 3M CO…	Kuraray Company, Ltd.	1994	—
*	K943167	Clearfil New Bond Summary page 1 …. (K943170) 2) CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. (K871636) 3) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. (K943165) 4) CLEARFIL NEW BOND by Kuraray Co., Ltd. (K943167) 5) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE (K942493) SYSTEM by 3M COMPANY 6) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL…	Kuraray Company, Ltd.	1994	—
*	K942493	Scotchbond Multi-Purpose Plus Dental Adhesive System Summary page 1 …(K871636) 3) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. (K943165) 4) CLEARFIL NEW BOND by Kuraray Co., Ltd. (K943167) 5) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE (K942493) SYSTEM by 3M COMPANY 6) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY 7 ALL-B…	3M Company	1994	—
*	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator Summary page 1 …NEW BOND by Kuraray Co., Ltd. (K943167) 5) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE (K942493) SYSTEM by 3M COMPANY 6) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY 7 ALL-BOND 2 by BISCO, INC. (K910860) 8) PROBOND by LD CAULK/DENTSPLY unknown 9) OPT…	Dentsply Intl.	1997	—
*	K910860	All-Bond 2 Summary page 1 …ADHESIVE (K942493) SYSTEM by 3M COMPANY 6) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY 7 ALL-BOND 2 by BISCO, INC. (K910860) 8) PROBOND by LD CAULK/DENTSPLY unknown 9) OPTIBOND by KERR MFG.CO (K934690) page 7 of 12 [CLEARFIL LINER BON…	Bisco, Inc.	1991	—
*	K934690	Kerr Optibond, Modification Summary page 1 …IN/ENAMEL (K964525) BONDING AGENT WITH ACTIVATOR by DENTSPLY 7 ALL-BOND 2 by BISCO, INC. (K910860) 8) PROBOND by LD CAULK/DENTSPLY unknown 9) OPTIBOND by KERR MFG.CO (K934690) page 7 of 12 [CLEARFIL LINER BOND 2V] 5. Description for the premarket notification CLEARFIL LINER BOND 2V is…	Kerr Corporation (Danbury)	1993	—
*	—	Probond Named without a submission number			—

Also cleared against K943170: 2 other devices →

What descends from it? (67)

See all 67

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

Number	Device	Applicant	Decided	Descendants
K990040	Clearfil SE Bond	Kuraray Co.	1999	64
K012440	Modification to Clearfil Liner Bond 2V	Kuraray Medical, Inc.	2001	11

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 5 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
None of the 13 ancestors has a recall.
Of its descendants, K990040 (Kuraray Co., 1999) has gone furthest, with 64 descendants of its own.
2 other devices also cite its predicate K943170.

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?

1) Direct filling restorations using light-cure or chemical-cure composite resin

2) Bonded amalgam restorations

3) Treatment of hypersensitive and/or exposed root surfaces

4) Cavity sealing as a pretreatment for indirect restorations

5) Intraoral repairs of facing crowns using light-cure composite resin

6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

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/K974486 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974486: Clearfil Liner Bond 2V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974486

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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