510(k) · Cleared
ClearedTokuso Mac Bond II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Apr 27, 1998 after a 111-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 27, 1998
- Review
- 111 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK980058 Tokuso Mac Bond IITokuyama America, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK993917 Tokuyama One-UP-Bond FTokuyama America, Inc. · 2000
- Descendant · 2 generations on · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · 3 generations on · 0 of its ownK070956 SEA2 Self Etch Adhesive3M Espe Dental Products · 2007
Most influential descendants
Showing 5 of 5 · See all- K993917Tokuyama One-UP-Bond FTokuyama America, Inc. · 2000 · cites it directly4descendants
- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · 2 generations on3descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 3 generations on0descendants
- K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013 · 3 generations on0descendants
- K070956SEA2 Self Etch Adhesive3M Espe Dental Products · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980058 | Tokuso Mac Bond II | Tokuyama America, Inc. | 1998 | — |
| +1 | K993917 | Tokuyama One-UP-Bond F | Tokuyama America, Inc. | 2000 | — |
| +2 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +3 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
| +3 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +3 | K070956 | SEA2 Self Etch Adhesive | 3M Espe Dental Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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 |
|---|---|---|---|
| * | — | Tokuso Light Bond Named without a submission number | |
| * | — | Scotchbond Adhesive System Named without a submission number | |
| * | — | Clearfil Liner Bond 2 Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993917 | Tokuyama One-UP-Bond F | 2000 | 4 |
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?
- Of its descendants, K993917 (Tokuyama America, Inc., 2000) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
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
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/K980058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980058: Tokuso Mac Bond II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980058
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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