510(k) · Cleared
ClearedClearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack
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 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.
- 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). No later device cites it as a predicate yet.
- 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 deviceK111975 Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory…Kuraray Medical, Inc. · 2011
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) | K111975 | Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack | Kuraray Medical, Inc. | 2011 | — |
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 |
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…0. Product code: KLE) 3) Common name Dental bonding agent 3-3. Predicate device 1) CLEARFIL TRI-S BOND 5 10(k) Number: K0429 13 Product Code: KLE 21 CFR Section:… | 2004 |
| * | K062382 | Clearfil DC BondSummary page 1…n: 872.3690 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL DC BOND 5 10(k) Number: K062382 Product Code: KLE 21 CFR Section:… | 2006 |
| * | K032455 | Panavia F 2.0Summary page 1…n: 872.3200 Applicant: KURARAY MEDICAL [NC. 3) PANA VIA F 2.0 5 10(k) Number: K032455 Product Code: EMA 21 CFR Section:… | 2003 |
| * | K063593 | Clearfil Majesty FlowSummary page 1…n: 872.3275 Applicant: KURARAY MEDICAL INC. 4) CLEARFIL MAJESTY Flow 5 10(k) Number: K063593 Product Code: EBF 21 CER Section:… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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?
(1) Direct restorations using light-cured composite resin
(2) Cavity sealing as a pretreatment for indirect restorations
(3) Treatment of exposed root surfaces
(4) Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
(5) Surface treatment of non-precious metal posts
(6) Post cementation and core build-ups using dual-cured composite resin CLEARFIL DC CORE PLUS
(7) Core build-ups using light-cured composite resin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111975: Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111975
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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