510(k) · Cleared
ClearedClearfil Porcelain Bond Activator
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 13, 2001 as substantially equivalent to K925404 (Kuraray Co., 1993) after a 30-day review. Its family tree reaches back 1 generation to 1993. 11 later devices descend from it.
- Decided
- Sep 13, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925404 (1993). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925404 Clearfil Porcelain Bond ActivatorKuraray Co. · 1993
- This deviceK012730 Clearfil Porcelain Bond ActivatorKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK061906 Clearfil Ceramic PrimerKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK024356 Clearfil Silane KitKuraray Medical, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK132450 Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial…Kuraray Noritake Dental, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K061906Clearfil Ceramic PrimerKuraray Medical, Inc. · 2006 · cites it directly9descendants
- K024356Clearfil Silane KitKuraray Medical, Inc. · 2003 · cites it directly4descendants
- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · 2 generations on3descendants
- K171449MetacemMeta Biomed Co., Ltd. · 2018 · 3 generations on1descendant
- K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925404 | Clearfil Porcelain Bond Activator | Kuraray Co. | 1993 | — |
| 0 (this device) | K012730 | Clearfil Porcelain Bond Activator | Kuraray Medical, Inc. | 2001 | — |
| +1 | K061906 | Clearfil Ceramic Primer | Kuraray Medical, Inc. | 2006 | — |
| +1 | K024356 | Clearfil Silane Kit | Kuraray Medical, Inc. | 2003 | — |
| +2 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +3 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +2 | K132450 | Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil… | Kuraray Noritake Dental, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K925404 | Clearfil Porcelain Bond ActivatorSummary page 1…er the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co., Ltd. (K925404) 4. Description for the premarket notification This product is contained in CLEARFIL PORCELAIN BOND (K871636) and CLEARFIL VENE… | 1993 |
What descends from it? (11)
See all 112 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?
- Its one ancestor has no recall.
- Of its descendants, K061906 (Kuraray Medical, Inc., 2006) has gone furthest, with 9 descendants of its own.
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?
CLEAFIL PORCELAIN BOND ACTIVATOR is indicated for the following applications:
1) Repair of porcelain or porcelain fused-to-metal crowns and bridges
2) Restoration of gingival porcelain areas where bonding to porcelain is necessary
3) Increased retention of porcelain inlays, onlays, crowns and veneers
4) Increased retention of composite inlays and onlays
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012730: Clearfil Porcelain Bond Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012730
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026