510(k) · Cleared
ClearedTokuyama One-UP-Bond F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama America, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Feb 2, 2000 as substantially equivalent to K980058 (Tokuyama America, Inc., 1998) after a 77-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Feb 2, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980058 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980058 Tokuso Mac Bond IITokuyama America, Inc. · 1998
- This deviceK993917 Tokuyama One-UP-Bond FTokuyama America, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · 2 generations on · 0 of its ownK070956 SEA2 Self Etch Adhesive3M Espe Dental Products · 2007
Most influential descendants
Showing 4 of 4 · See all- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · cites it directly3descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 2 generations on0descendants
- K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013 · 2 generations on0descendants
- K070956SEA2 Self Etch Adhesive3M Espe Dental Products · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980058 | Tokuso Mac Bond II | Tokuyama America, Inc. | 1998 | — |
| 0 (this device) | K993917 | Tokuyama One-UP-Bond F | Tokuyama America, Inc. | 2000 | — |
| +1 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +2 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
| +2 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +2 | K070956 | SEA2 Self Etch Adhesive | 3M Espe Dental Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K980058 | Tokuso Mac Bond IISummary page 1…s received the approval of the Japanese Government. The product is substantially equivalent to various marketed bondirig agents, including Tokuyama’s Tokuso Mac Bond Il (K980058). “‘fl astiny, N e, 9, {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administra… | 1998 |
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 |
|---|---|---|---|
| K023842 | Clearfil SE Bond Plus | 2003 | 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?
- Its one ancestor has no recall.
- Of its descendants, K023842 (Kuraray Medical, Inc., 2003) has gone furthest, with 3 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?
For use in dental procedures as a bonding primer with light cured resin
filling material to enhance the adhesion of resin filling material to the
tooth and for sealing of exposed cervical dentin and root surfaces.
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/K993917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993917: Tokuyama One-UP-Bond F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993917
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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