510(k) · Cleared
ClearedG-Bond Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 2, 2025 as substantially equivalent to K143140 (GC America, Inc., 2015) and 1 other predicate after a 174-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Oct 2, 2025
- Review
- 174 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011200 (2001). 12 ancestors in all, the oldest K992326 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK011200 Gilb, Model 80103M Company · 2001
- 3 generations backK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- 2 generations backK091632 SPK Sealant3M Company · 2009
- 1 generation backK100062 Infiltration KitDmg USA, Inc. · 2010
- This deviceK251124 G-Bond UniversalGC America, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011200 | Gilb, Model 8010 | 3M Company | 2001 | — |
| −3 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| −2 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| −1 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| 0 (this device) | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K143140 | G-Premio BONDSummary page 5…icate Devices: Product Applicant 510(k) No. Code No. Predicate Decision Date G-Premio BOND GC America Inc. K143140 KLE Primary 04/20/2015 Icon (INFILTRATION DMG USA, Inc K100062… | 2015 |
| * | K100062 | Infiltration KitSummary page 5…G-Premio BOND GC America Inc. K143140 KLE Primary 04/20/2015 Icon (INFILTRATION DMG USA, Inc K100062 EBC Secondary 03/26/2010 KIT) 3M Deutschland Scotchbond Universal… | 2010 |
| † | K192961 | ADH19 | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K143140.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
1. Direct bonding of restorative materials
2. Bonding of dual-cured core build up composites
3. Adhesive cementation of indirect restorations
4. Priming of adherent surface of indirect restorations
5. Intraoral repair of fractured restorations
6. Treatment of hypersensitive teeth
7. Sealing of tooth preparation (cavity or abutment) for indirect restorations
8. Treatment of exposed root surfaces
9. Micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions
10. Post cementation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251124: G-Bond Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251124
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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