510(k) · Cleared
ClearedClearfil DC 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 27, 2006 as substantially equivalent to K042913 (Kuraray Medical, Inc., 2004) and 2 other predicates after a 43-day review. Its family tree reaches back 6 generations to 1993. 6 later devices descend from it.
- Decided
- Sep 27, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931812 (1993). 17 ancestors in all, the oldest K871636 (1987). 6 later devices descend from it, 3 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 backK012440 Modification to Clearfil Liner Bond 2VKuraray Medical, Inc. · 2001
- This deviceK062382 Clearfil DC BondKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- Descendant · 2 generations on · 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 · 3 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K111980Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011 · cites it directly4descendants
- K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc. · 2013 · 2 generations on1descendant
- 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 · 3 generations on0descendants
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 | K012440 | Modification to Clearfil Liner Bond 2V | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K062382 | Clearfil DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +1 | K111980 | Clearfil Tri-S Bond Plus | Kuraray America, Inc. | 2011 | — |
| +2 | 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 | — |
| +3 | 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 | 5 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 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? (3)
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…Common name Resin-based dental adhesive system 3. Predicate device 1) CLEARFIL TRI-S BOND 510(k) Number: K042913 Product Code: KLE 21 CFR… | 2004 |
| * | K012440 | Modification to Clearfil Liner Bond 2VSummary page 1…872.3200 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL LINER BOND 2V 510(k) Number: K012440 Product Code: KLE 21 CFR… | 2001 |
| * | K012432 | Modification to Clearfil Photo BondSummary page 1…72.3200 Applicant: KURARAY MEDICAL, INC. 3) CLEARFIL PHOTO BOND 510(k) Number: K012432 Product Code: KLE 21 CFR… | 2001 |
What descends from it? (6)
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 13 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K111980 (Kuraray America, Inc., 2011) has gone furthest, with 4 descendants 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.
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) Core build-ups using light-, dual-, or self-cure composite resin
2) Direct restorations using light-cure composite resin
3) Direct restorations using self-cure composite resin
4) Cavity scaling as a pretreatment for indirect restorations
5) Treatment of exposed root surfaces
6) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics,
hybrid ceramics or composite resin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062382: Clearfil DC Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062382
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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