510(k) · Cleared
ClearedClearfil SE Bond Plus
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 Feb 11, 2003 as substantially equivalent to K012442 (Kuraray Medical, Inc., 2001) and 9 other predicates after an 85-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Feb 11, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 7 generations to K931812 (1993). 37 ancestors in all, the oldest K855211 (1986). 3 later devices descend from it, 3 citing it directly.
- 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 deviceK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · cites it directly · 0 of its ownK070956 SEA2 Self Etch Adhesive3M Espe Dental Products · 2007
Most influential descendants
Showing 3 of 3 · See allView 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) | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +1 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
| +1 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +1 | K070956 | SEA2 Self Etch Adhesive | 3M Espe Dental Products | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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? (10)
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 |
|---|---|---|---|
| * | K012442 | Modification to Clearfil SE Bond | 2001 |
| * | K012440 | Modification to Clearfil Liner Bond 2V | 2001 |
| * | K993917 | Tokuyama One-UP-Bond FSummary page 1…INER BOND 2V by Kuraray Medical Inc. (KO 12440) 3. TOKUYAMA ONE-UP-BOND F by Tokuyama America Inc. (K993917) 4. IMPERVA FLUOR0 BOND by Shofu Dental Corp. (K953612) 5. PRIME & BOND… | 2000 |
| * | K953612 | Imperva FluorobondSummary page 1…ONE-UP-BOND F by Tokuyama America Inc. (K993917) 4. IMPERVA FLUOR0 BOND by Shofu Dental Corp. (K953612) 5. PRIME & BOND NT DUAL CURE by Dentsply Intl. (K982394) UNIVERSAL DE… | 1995 |
| * | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive SystemSummary page 1…LUOR0 BOND by Shofu Dental Corp. (K953612) 5. PRIME & BOND NT DUAL CURE by Dentsply Intl. (K982394) UNIVERSAL DENTAL ADHESIVE SYSTEM 6. OPTIBOND SOLO PLUS 4 by KERR DENTAL… | 1998 |
| * | K014027 | Optibond Solo Plus 4 | 2002 |
| * | K012441 | Panavia F | 2001 |
| * | K021805 | Seal & Protect Protective SealantSummary page 1…by Kuraray Medical Inc. (KO12441) 2. SEAL & PROTECT PROTECTIVE SEALANT by Dentsply Intl. (K021805) 3. PANAVIAEX by Kuraray Co., Ltd. (K855211) 4. ESTENIA… | 2002 |
| * | K855211 | Panavia EX, a Dental AdhesiveSummary page 1…PROTECTIVE SEALANT by Dentsply Intl. (K021805) 3. PANAVIAEX by Kuraray Co., Ltd. (K855211) 4. ESTENIA by Kuraray Medical Inc. (IC012707) 1. Description for the… | 1986 |
| * | K012707 | EsteniaSummary page 1…by Kuraray Co., Ltd. (K855211) 4. ESTENIA by Kuraray Medical Inc. (IC012707) 1. Description for the premarket notification CLEARFIL SE BOND PLUS is classified into the resin tooth bonding agent, CF… | 2001 |
What descends from it? (3)
3 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 10 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K183391 (Nobio, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K012442.
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?
CLEARFIL SE BOND PLUS is indicated for the following applications:
1) Direct restorations using light-cured composite resin 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 crowns/bridges made of porcelain, hybrid ceramics or composite resin using light-cured composite resin
5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
6) Core build-ups using light- or dual-cured composite resin
7) Cavity sealing under amalgam restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023842: Clearfil SE Bond Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023842
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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