# K041471: G-BOND

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 29, 2004 after 27 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110403: Prolink Adhesives (Prolink, Prolink SE) (2011), 1 descendant of its own
- K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (2023), 0 descendants of its own

## Indications for use
This product is a light-cured dentin bonding agent to provide effective bonding to resin composite restorative materials.

Source page: https://510kreport.com/device/K041471
Methodology: https://510kreport.com/methodology