# K040548: Aegis Ortho Light-Cured Orthodontic Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Mar 19, 2004 after 17 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
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light. The orthodontic adhesive can also be used to bond orthodontic bands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive). The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, veneer, inlay, only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adhesive.

Source page: https://510kreport.com/device/K040548
Methodology: https://510kreport.com/methodology