510(k) · Cleared
ClearedModification to Clearfil SE Bond
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 10, 2001 as substantially equivalent to K990040 (Kuraray Co., 1999) after a 41-day review. Its family tree reaches back 6 generations to 1993. 60 later devices descend from it.
- Decided
- Sep 10, 2001
- Review
- 41 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931812 (1993). 16 ancestors in all, the oldest K871636 (1987). 60 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 1 generation backK990040 Clearfil SE BondKuraray Co. · 1999
- This deviceK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- Descendant · 2 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
- Descendant · 2 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 17 of its ownK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · cites it directly34descendants
- K094007Unicem3M Espe AG Dental Products · 2010 · 2 generations on22descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · 2 generations on19descendants
- K063593Clearfil Majesty FlowKuraray America, Inc. · 2007 · cites it directly17descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −1 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| 0 (this device) | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| +1 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| +2 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| +2 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| +1 | K063593 | Clearfil Majesty Flow | Kuraray America, Inc. | 2007 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 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 |
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 |
|---|---|---|---|
| * | K990040 | Clearfil SE BondSummary page 1…ssion is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL SE BOND by Kuraray Co., Ltd. (K990040) 4. Description for the premarket notification CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section… | 1999 |
What descends from it? (60)
See all 6010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032455 | Panavia F 2.0 | 2003 | 34 |
| K063593 | Clearfil Majesty Flow | 2007 | 17 |
| K042929 | Estenia C&B | 2004 | 12 |
| K061906 | Clearfil Ceramic Primer | 2006 | 9 |
| K063595 | Clearfil Majesty Posterior | 2007 | 4 |
| K024356 | Clearfil Silane Kit | 2003 | 4 |
| K023842 | Clearfil SE Bond Plus | 2003 | 3 |
| K131432 | Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack… | 2013 | 1 |
| K070956 | SEA2 Self Etch Adhesive | 2007 | 0 |
| K022999 | Clearfil AP-X PLT Intro Kit | 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 8 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K032455 (Kuraray Medical, Inc., 2003) has gone furthest, with 34 descendants of its own.
- 4 other devices also cite its predicate K990040.
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 SE BOND is indicated for the following applications:
Direct filling restorations using light-curing composite or compomer
Cavity sealing as a pretreatment for indirect restorations
Treatment of hypersensitive and/or exposed root surfaces
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite
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/K012442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012442: Modification to 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/K012442
Report an extraction error
Are you the manufacturer?
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