# K242537: BracePaste Fluoride Sealant

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics Corp.
- Decided: Aug 27, 2024 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: 2 generations back to K023042 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090355: Opal Seal, Ultradent Products, Inc. (2009) Summary page 4.

## Indications for use
BracePaste Fluoride Sealant is a light-cure primer/ sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bendable devices by preparing the bonding surface during orthodontic treatment to the etched enamel. BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

Source page: https://510kreport.com/device/K242537
Methodology: https://510kreport.com/methodology