# K150128: GC Ortho Connect, GC Ortho Etching Gel

- Pathway: 510(k) (Traditional)
- Applicant: Gc Orthodontics America, Inc.
- Decided: Jul 16, 2015 after 177 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K261129: OrthoFit (2026), 0 descendants of its own

## Indications for use
GC Ortho Connect 1. Bonding metal brackets and attachments 2. Bonding ceramic brackets 3. Bonding plastic brackets and acrylic appliances GC Ortho Etching Gel 1. Etching enamel of tooth surfaces 2. Enhancing the bond strength of light-cured orthodontic adhesive materials

Source page: https://510kreport.com/device/K150128
Methodology: https://510kreport.com/methodology