510(k) · Cleared
ClearedModification to Clearfil Liner Bond 2V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Sep 5, 2001 as substantially equivalent to K974486 (Kuraray America, Inc., 1998) after a 36-day review. Its family tree reaches back 5 generations to 1993. 11 later devices descend from it.
- Decided
- Sep 5, 2001
- Review
- 36 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931812 (1993). 14 ancestors in all, the oldest K871636 (1987). 11 later devices descend from it, 2 citing it directly.
- 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 deviceK012440 Modification to Clearfil Liner Bond 2VKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK062382 Clearfil DC BondKuraray Medical, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK131432 Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE…Kuraray Noritake Dental, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062382Clearfil DC BondKuraray Medical, Inc. · 2006 · cites it directly6descendants
- K111980Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011 · 2 generations on4descendants
- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · cites it directly3descendants
- K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc. · 2013 · 3 generations on1descendant
- K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc. · 2013 · 2 generations on1descendant
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) | K012440 | Modification to Clearfil Liner Bond 2V | Kuraray Medical, Inc. | 2001 | — |
| +1 | K062382 | Clearfil DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +2 | K111980 | Clearfil Tri-S Bond Plus | Kuraray America, Inc. | 2011 | — |
| +1 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +3 | K132450 | Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +2 | K131432 | Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2… | Kuraray Noritake Dental, Inc. | 2013 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K974486 | Clearfil Liner Bond 2VSummary page 1…on is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL LINER BOND 2V by Kuraray Co., Ltd. (K974486) 4. Description for the premarket notification CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21… | 1998 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K062382 (Kuraray Medical, Inc., 2006) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K974486.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 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?
CLEAFIL LINER BOND 2V is indicated for the following applications:
Direct filling restorations using light-cure or chemical-cure composite resin
Bonded amalgam restorations
Treatment of hypersensitive and/or exposed root surfaces
Cavity sealing as a pretreatment for indirect restorations
Intraoral repairs of facing crowns using light-cure composite resin
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/K012440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012440: Modification to Clearfil Liner Bond 2V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012440
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026