# K251124: G-Bond Universal

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 2, 2025 after 174 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 K011200 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143140: G-Premio BOND, GC America, Inc. (2015) Summary page 5.
- K100062: Infiltration Kit, Dmg USA, Inc. (2010) Summary page 5.

## Indications for use
1. Direct bonding of restorative materials 2. Bonding of dual-cured core build up composites 3. Adhesive cementation of indirect restorations 4. Priming of adherent surface of indirect restorations 5. Intraoral repair of fractured restorations 6. Treatment of hypersensitive teeth 7. Sealing of tooth preparation (cavity or abutment) for indirect restorations 8. Treatment of exposed root surfaces 9. Micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions 10. Post cementation

Source page: https://510kreport.com/device/K251124
Methodology: https://510kreport.com/methodology