510(k) · Cleared
ClearedClearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Nov 1, 2013 as substantially equivalent to K111980 (Kuraray America, Inc., 2011) and 2 other predicates after an 87-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Nov 1, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931812 (1993). 32 ancestors in all, the oldest K871636 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations between
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 1 generation backK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- This deviceK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK192913 R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021
Show all 9 generations
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 5 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 4 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 1 generation backK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- This deviceK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −8 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −5 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −4 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −3 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −2 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −1 | K111980 | Clearfil Tri-S Bond Plus | Kuraray America, Inc. | 2011 | — |
| 0 (this device) | K132450 | Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +1 | K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (4)
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 |
|---|---|---|---|
| * | K111980 | Clearfil Tri-S Bond Plus | 2011 |
| * | K042913 | Clearfil Tri-S BondSummary page 1…872.3200 Applicant: 3M ESPE 3) CLEARFIL TRI-S BOND 5 10(k) Number: K042913 Classification: Agent, Tooth Bonding, Resin… | 2004 |
| * | K061906 | Clearfil Ceramic PrimerSummary page 1…Applicant: Kuraray Noritake Dental Inc. 4) CLEARFIL CERAMIC PRIMER 510(k) Number: K061906 Classification: Material, Tooth shade, Resin… | 2006 |
| * | — | Scotebbond Universal Adhesive Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | 2021 | 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 20 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 32 ancestors has a recall.
- Of its descendants, K192913 (Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111980.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
[1] Direct restorations using light-cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] lntraoral repairs of fractured restorations
[6] Post cementation and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132450
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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