510(k) · Cleared
ClearedAce Bond SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 19, 2007 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 10 later devices descend from it.
- Decided
- Jan 19, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
10 later devices descend from it, 2 citing it directly.
- This deviceK063780 Ace Bond SEBisco, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK240743 Peak Universal BondUltradent Products, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK213401 DIAPLUS UniversalDiaDent Group International · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112118DreambondBisco, Inc. · 2011 · cites it directly8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 2 generations on6descendants
- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · 3 generations on2descendants
- K240743Peak Universal BondUltradent Products, Inc. · 2024 · 4 generations on1descendant
- K213401DIAPLUS UniversalDiaDent Group International · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063780 | Ace Bond SE | Bisco, Inc. | 2007 | — |
| +1 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +2 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +3 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
| +4 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 | — |
| +3 | K213401 | DIAPLUS Universal | DiaDent Group International | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K050647 | FDA’s K050647 is All-in-One Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it? (10)
2 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?
- Of its descendants, K112118 (Bisco, Inc., 2011) has gone furthest, with 8 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. 2007, 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?
As a Universal Self-Etching Adhesive System, ACE BOND SE, as the name implies, is
the only product one needs to etch, prime, and bond to a tooth structure and dental
substrates.
ACE BOND SE is used for:
1.Direct restorations (composite, amalgam)
2. All indirect restorations (composite, metal, porcelain)
3. Desensitization of crown preparations prior to impression making/provisionatization
4. Composite core build-ups
5. Composite to metal/set amalgam (direct veneering)
6. Root desensitization
7. New amalgam to existing amalgam
8. Repairs (composite-to-composite, composite-to-porcelain)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063780: Ace Bond SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063780
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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