# K103585: Bosworth Aegis Liner & Restorative Material W/Acp

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Mar 4, 2011 after 87 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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
Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

Source page: https://510kreport.com/device/K103585
Methodology: https://510kreport.com/methodology