# K043043: Hermes Bond 2

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Jan 10, 2005 after 67 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: 4 generations back to K900510 (1990). 13 ancestors in all.
37 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020946: Adper Prompt, 3M Espe AG Dental Products (2002) Summary page 1.
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K033022: Protemp 3 Garant, 3M Espe AG Dental Products (2003) Summary page 1.

## Most influential descendants
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- 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

## Indications for use
Bonding between dentin/enamel and silorane based composite filling materials Bonding between dentin/enamel and methacrylate based composite filling materials Bonding mediator for fissure sealing

Source page: https://510kreport.com/device/K043043
Methodology: https://510kreport.com/methodology