# K033751: Aegis Pit & Fissure Sealant with Acp

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Feb 5, 2004 after 66 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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
Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.

Source page: https://510kreport.com/device/K033751
Methodology: https://510kreport.com/methodology