# K033974: Hermes Bond

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Feb 6, 2004 after 46 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.
No later device cites it as a predicate yet.
0 of 14 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.
- K010781: 3M Espe Haur, 3M Company (2001) Summary page 1.

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

Source page: https://510kreport.com/device/K033974
Methodology: https://510kreport.com/methodology