# K160782: BracePaste Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Oct 14, 2016 after 206 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
Longest line of descent: 1 generation back to K880393 (1988). 1 ancestor in all.
1 later device descends 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)
- K880393: Transbond Light Cured Orthodontic Adhesive, Unitek Corp. (1988) Summary page 4.

## Most influential descendants
- K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (2022), 0 descendants of its own

## Indications for use
American Orthodontics’ BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

Source page: https://510kreport.com/device/K160782
Methodology: https://510kreport.com/methodology