510(k) · Cleared
ClearedFuturabond Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · KLE Agent, Tooth Bonding, Resin
Cleared on Jun 20, 2013 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 20, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
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 |
|---|---|---|---|---|---|
| 0 (this device) | K130486 | Futurabond Universal | Voco GmbH | 2013 | — |
| +1 | K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | 2017 | — |
| +2 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021 | — |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
- Of its descendants, K171226 (Tokuyama Dental Corporation, 2017) has gone furthest, with 1 descendant 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. 2013, this device’s year, is highlighted.
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?
Futurabond Universal is intended for use as: Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base Adhesive for core build-ups made of light-curing composite materials Adhesive for indirect restorations with light-curing luting composites Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional…
Read the full statement (129 words)
Futurabond Universal is intended for use as:
Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
Adhesive for core build-ups made of light-curing composite materials
Adhesive for indirect restorations with light-curing luting composites
Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
Treatment of hypersensitive tooth necks
Protective vamish for glass ionomer cement restorations
Sealing of cavities prior to amalgam restorations
Sealing of cavities and core preparations pnor to the temporary luting of indirect restorations
Adhesive for direct self-curing or dual-curing .composite restorations of all classes of cavities and for core build-ups
Adhesive for indirect restorations using dual-curing or self-curing luting composites
Luting of root posts with dual-curing or self-curing luting composites
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/K130486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130486: Futurabond Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130486
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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