# K071260: Hermes Bond 3

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Jul 17, 2007 after 71 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: 5 generations back to K900510 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043043: Hermes Bond 2, 3M Espe AG Dental Products (2005) Summary page 1.
- K060684: Adper Prompt, Adper Prompt L-Pop, 3M Espe AG Dental Products (2006) Summary page 1.
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K913965: Espe (R) -Sil, Espe GmbH (Us) (1991) Summary page 1.
- K992645: Sinfony, Espe Dental AG (1999) Summary page 1.

## Indications for use
Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites

Source page: https://510kreport.com/device/K071260
Methodology: https://510kreport.com/methodology