# K080724: GC OPB-100

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 11, 2008 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
GC OPB-100 is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns (e.g., Herbst or expansion appliances).

Source page: https://510kreport.com/device/K080724
Methodology: https://510kreport.com/methodology