510(k) · Cleared
ClearedModification to Alloy Primer
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 4, 2001 as substantially equivalent to K974089 (Kuraray America, Inc., 1997) after a 35-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Sep 4, 2001
- Review
- 35 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871636 (1987). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871636 Clearfil Porcelain BondKuraray Co. · 1987
- 1 generation backK974089 Alloy PrimerKuraray America, Inc. · 1997
- This deviceK012436 Modification to Alloy PrimerKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK171226 Tokuyama Universal BondTokuyama Dental Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK203760 Tokuyama Universal Bond IITokuyama Dental Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871636 | Clearfil Porcelain Bond | Kuraray Co. | 1987 | — |
| −1 | K974089 | Alloy Primer | Kuraray America, Inc. | 1997 | — |
| 0 (this device) | K012436 | Modification to Alloy Primer | Kuraray Medical, Inc. | 2001 | — |
| +1 | K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | 2017 | — |
| +2 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K974089 | Alloy PrimerSummary page 1…) submission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. ALLOY PRIMER by Kuraray Co., Ltd. (K974089) 4. Description for the premarket notification ALLOY PRIMER is an adhesion primer between dental metal alloy and resin-based mat… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171226 | Tokuyama Universal Bond | 2017 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171226 (Tokuyama Dental Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K974089.
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?
ALLOY PRIMER is indicated for the following applications:
1) Adhesion of metal posts, metal inlays, onlays, crown and bridges
2) Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures
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/K012436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012436: Modification to Alloy Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012436
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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