510(k) · Cleared
ClearedClearfil Tri-S Bond Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray America, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 14, 2011 as substantially equivalent to K042913 (Kuraray Medical, Inc., 2004) and 3 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1993. 4 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 94 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931812 (1993). 27 ancestors in all, the oldest K871636 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 4 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 3 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 2 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 1 generation backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- This deviceK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK131432 Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE…Kuraray Noritake Dental, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK231696 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew…Prevest Denpro Limited · 2023
- Descendant · 2 generations on · 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
Most influential descendants
Showing 4 of 4 · See all- K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc. · 2013 · cites it directly1descendant
- K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc. · 2013 · cites it directly1descendant
- K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited · 2023 · 2 generations on0descendants
- K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −7 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −4 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −3 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −1 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| 0 (this device) | K111980 | Clearfil Tri-S Bond Plus | Kuraray America, Inc. | 2011 | — |
| +1 | K132450 | Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +1 | K131432 | Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2… | Kuraray Noritake Dental, Inc. | 2013 | — |
| +2 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | 2023 | — |
| +2 | 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 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K042913 | Clearfil Tri-S BondSummary page 1…2.3690. Product code: KLE) 3) Common name Dental bonding agent 3-3. Predicate device 1) CLEARFIL TRI-S BOND 510(k) Number: K042913 Product Code: KLE 21 CFR Section: 872.369… | 2004 |
| * | K062382 | Clearfil DC BondSummary page 1…21 CFR Section: 872.3690 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL DC BOND 510(k) Number: K062382 Product Code: KLE 21 CFR Section: 872.320… | 2006 |
| * | K032455 | Panavia F 2.0Summary page 1…21 CFR Section: 872.3200 Applicant: KURARAY MEDICAL INC. 3) PANAVIA F 2.0 5 10(k) Number: K032455 Product Code: EMA 21 CFR Section: 872.327… | 2003 |
| * | K063593 | Clearfil Majesty FlowSummary page 1…21 CFR Section: 872.3275 Applicant: KURARAY MEDICAL INC. 4) CLEARFIL MAJESTY Flow 5 10(k) Number: K063593 Product Code: EUF 21 CFR Section: 872.369… | 2007 |
What descends from it? (4)
2 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 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K132450 (Kuraray Noritake Dental, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K042913.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Direct restorations using light-cured composite resin
Cavity sealing as a pretreatment for indirect restorations
Treatment of exposed root surfaces
Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin
Surface treatment of dental posts
Post cementation and core build-ups using dual-cured composite resin CLEARFIL DC CORE PLUS
Core build-ups using light-cured composite resin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111980 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111980: Clearfil Tri-S Bond Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111980
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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