# K261840: BracePaste Prime Plus

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Jun 3, 2026 after 1 day
- 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: 9 generations back to K900510 (1990). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161051: All-Bond Universal w/BAC (not finalized), Bisco, Inc. (2016) Summary page 5.

## Indications for use
BracePaste Prime Plus is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment. BracePaste Prime Plus is indicated for the following bonding surfaces: any dental structure containing zirconia, alumina, metals, glass ceramic, dentin, enamel, and composites.

Source page: https://510kreport.com/device/K261840
Methodology: https://510kreport.com/methodology