510(k) · Cleared
ClearedAdhesive Exl-759
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG · KLE Agent, Tooth Bonding, Resin
Cleared on May 19, 2011 as substantially equivalent to K071131 (3M Espe AG Dental Products, 2007) and 2 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1990. 34 later devices descend from it.
- Decided
- May 19, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K900510 (1990). 35 ancestors in all, the oldest K833757 (1984). 34 later devices descend from it, 15 citing it directly.
- Root · 6 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 5 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 4 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 3 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 2 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 1 generation backK071131 UNO3M Espe AG Dental Products · 2007
- This deviceK110302 Adhesive Exl-7593M Espe AG · 2011
- 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 · cites it directly · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK200798 G-Cem OneGC America, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K112118DreambondBisco, Inc. · 2011 · cites it directly8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 2 generations on6descendants
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · cites it directly5descendants
- K200798G-Cem OneGC America, Inc. · 2020 · 2 generations on3descendants
- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −5 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −4 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −3 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −2 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| 0 (this device) | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +1 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +2 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +1 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
| +2 | K200798 | G-Cem One | GC America, Inc. | 2020 | — |
| +3 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K071131 | UNOSummary page 1…................................................ Adhesive Predicate Devices Uno by 3M ESPE, Germany............................................... K071 131 3M Dent System by 3M ESPE Dental Products, USA ................. K962785 Scotchprime Ceramic Primer by 3M ESPE De… | 2007 |
| * | K962785 | 3M Dent SystemSummary page 1…no by 3M ESPE, Germany............................................... K071 131 3M Dent System by 3M ESPE Dental Products, USA ................. K962785 Scotchprime Ceramic Primer by 3M ESPE Dental Products, USA..K853698 Description for the Premarket Notification A… | 1996 |
| * | K853698 | Scotchprime Ceramic PrimerSummary page 1…. K071 131 3M Dent System by 3M ESPE Dental Products, USA ................. K962785 Scotchprime Ceramic Primer by 3M ESPE Dental Products, USA..K853698 Description for the Premarket Notification Adhesive EXL 759, manufactured by 3M ESPE, is classified as a Resin t… | 1985 |
What descends from it? (34)
See all 3415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112118 | Dreambond | 2011 | 8 |
| K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | 2016 | 5 |
| K192961 | ADH19 | 2019 | 2 |
| K133318 | Adhese Universal | 2014 | 2 |
| K241445 | K-Bond Universal | 2024 | 1 |
| K222581 | Stela Automix System | 2022 | 1 |
| K171226 | Tokuyama Universal Bond | 2017 | 1 |
| K252151 | els unibond | 2025 | 0 |
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | 2025 | 0 |
| K230009 | EZ Bond Universal | 2023 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 35 ancestors has a recall of any class.
- 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. 2011, 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?
All classes of fillings (according to Black) with light-curing composite or compomner filling materials Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of composite, compomner, ceramic, and metal when combined with Suglue-l10 Adhesive Resin Cement, manufactured by 3M ESPE Cementation of veneers when combined with RelyX Veneer Cement, manufactured by 3M ESPE Bonding of core build-ups made of light-curing composite or core…
Read the full statement (154 words)
All classes of fillings (according to Black) with light-curing composite or compomner filling materials
Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of composite, compomner, ceramic, and metal when combined with Suglue-l10 Adhesive Resin Cement, manufactured by 3M ESPE
Cementation of veneers when combined with RelyX Veneer Cement, manufactured by 3M ESPE
Bonding of core build-ups made of light-curing composite or core build-up materials
Bonding of dual-cure cements and core build-up materials and self-cure composites when combined with Activator EXL 760
Repair of composite or compomner fillings
Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
Root surface desensitization
Sealing of cavities prior to cementation of amalgamate restorations
Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
Bonding of fissure sealants
Protective varnish for glass ionomer fillings
Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and alumina), metal and composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110302 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110302: Adhesive Exl-759.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110302
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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