# K110302: Adhesive Exl-759

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG
- Decided: May 19, 2011 after 106 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K900510 (1990). 35 ancestors in all.
34 later devices descend from it; 15 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071131: UNO, 3M Espe AG Dental Products (2007) Summary page 1.
- K962785: 3M Dent System, 3M Company (1996) Summary page 1.
- K853698: Scotchprime Ceramic Primer, 3M Company (1985) Summary page 1.

## Most influential descendants
- K112118: Dreambond (2011), 8 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (2016), 5 descendants of its own
- K200798: G-Cem One (2020), 3 descendants of its own
- K230465: Hi-Bond Universal (2023), 2 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K110302
Methodology: https://510kreport.com/methodology