# K082768: G-Bond Plus

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 21, 2008 after 29 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K143140: G-Premio BOND (2015), 2 descendants of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own
- K200682: BZF-29 (2020), 0 descendants of its own

## Indications for use
G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.

Source page: https://510kreport.com/device/K082768
Methodology: https://510kreport.com/methodology