510(k) · Cleared
ClearedClearfil Silane Kit
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 Mar 26, 2003 as substantially equivalent to K012442 (Kuraray Medical, Inc., 2001) and 2 other predicates after an 86-day review. Its family tree reaches back 7 generations to 1993. 4 later devices descend from it.
- Decided
- Mar 26, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931812 (1993). 20 ancestors in all, the oldest K871636 (1987). 4 later devices descend from it, 1 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 deviceK024356 Clearfil Silane KitKuraray Medical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK180802 Meta P&BondMeta Biomed Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
- K171449MetacemMeta Biomed Co., Ltd. · 2018 · 2 generations on1descendant
- K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants
- K180802Meta P&BondMeta Biomed Co., Ltd. · 2018 · 2 generations on0descendants
View 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) | K024356 | Clearfil Silane Kit | Kuraray Medical, Inc. | 2003 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +3 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
| +2 | K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K012442 | Modification to Clearfil SE BondSummary page 1…cured composite resin Predicate device: The predicate devices are as follows. 1) CLEARFIL SE BOND manufactured by Kuraray Medical Inc. (K012442) 2) ClLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Medical Inc. (K012730) 3) C!LEARFIL PHOTO BOND manu… | 2001 |
| * | K012730 | Clearfil Porcelain Bond ActivatorSummary page 1…as follows. 1) CLEARFIL SE BOND manufactured by Kuraray Medical Inc. (K012442) 2) ClLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Medical Inc. (K012730) 3) C!LEARFIL PHOTO BOND manufactured by Kuraray Medical Inc. (KO12432) Description for the premarket notification CLE.4… | 2001 |
| * | K012432 | Modification to Clearfil Photo Bond | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | 2008 | 3 |
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.
- None of the 20 ancestors has a recall.
- Of its descendants, K081913 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 3 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 SILANE KIT is indicated for the following applications:
1) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite.
2) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024356: Clearfil Silane Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024356
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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