510(k) · Cleared
ClearedAlloy Primer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray America, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Dec 17, 1997 as substantially equivalent to K942017 (Parkell, Inc., 1994) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Dec 17, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K871636 (1987). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK871636 Clearfil Porcelain BondKuraray Co. · 1987
- This deviceK974089 Alloy PrimerKuraray America, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK012436 Modification to Alloy PrimerKuraray Medical, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK171226 Tokuyama Universal BondTokuyama Dental Corporation · 2017
- Descendant · cites it directly · 0 of its ownK251587 VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026
- Descendant · 3 generations on · 0 of its ownK203760 Tokuyama Universal Bond IITokuyama Dental Corporation · 2021
- Descendant · cites it directly · 0 of its ownK052189 Reveneer Ceramic Repair SystemSchutz-Dental GmbH · 2005
Most influential descendants
Showing 5 of 5 · See all- K012436Modification to Alloy PrimerKuraray Medical, Inc. · 2001 · cites it directly2descendants
- K171226Tokuyama Universal BondTokuyama Dental Corporation · 2017 · 2 generations on1descendant
- K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026 · cites it directly0descendants
- K203760Tokuyama Universal Bond IITokuyama Dental Corporation · 2021 · 3 generations on0descendants
- K052189Reveneer Ceramic Repair SystemSchutz-Dental GmbH · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871636 | Clearfil Porcelain Bond | Kuraray Co. | 1987 | — |
| 0 (this device) | K974089 | Alloy Primer | Kuraray America, Inc. | 1997 | — |
| +1 | K012436 | Modification to Alloy Primer | Kuraray Medical, Inc. | 2001 | — |
| +2 | K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | 2017 | — |
| +1 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026 | — |
| +3 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021 | — |
| +1 | K052189 | Reveneer Ceramic Repair System | Schutz-Dental GmbH | 2005 | — |
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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K942017 | V-Primer Our OCR of the scanned summary read K942917, FDA’s number for Ultrapro Workstation (Ramsoft, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “V-PRIMER”. | 1994 |
| * | K970848 | Siloc SystemSummary page 3…use are same _ to those of predicate devices. ' 1) Adhesion of metal posts, metal mlays, onlays, crown and bridges. Similar products V-PRIMER (K942917) SILOC SYSTEM (K970848) 2)Repair of fractures resin-based facmg crowns and porcelain-fused metal crowns Similar product CLEARFIL PORCELAIN BOND (K87163… | 1997 |
| * | K871636 | Clearfil Porcelain BondSummary page 3…ucts V-PRIMER (K942917) SILOC SYSTEM (K970848) 2)Repair of fractures resin-based facmg crowns and porcelain-fused metal crowns Similar product CLEARFIL PORCELAIN BOND (K871636) 3)Fabrication of removable dentures mth metal base, clasp or attachment. Repair of dentures Similar product ACRYLIC SOLDER by… | 1987 |
| * | — | ACRYLIC SOLDER by PARKELL PRODUCT, INC. Named without a submission number |
What descends from it? (5)
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K012436 (Kuraray Medical, Inc., 2001) has gone furthest, with 2 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?
This device is used for the following indications. All of these intended use are same to those of predicate devices.
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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974089: Alloy Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974089
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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