# K122521: Prevent Seal

- Pathway: 510(k) (Traditional)
- Applicant: Itena Clinical
- Decided: Jun 11, 2013 after 295 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
Longest line of descent: 1 generation back to K932078 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932078: Helioseal F, Ivoclar North America, Inc. (1993) Summary page 1.
- K103528: Ips Empress Direct Flow, Ivoclar Vivadent, Inc. (2011) Summary page 1.

## Most influential descendants
- K141717: Pacseal Pit & Fissure Sealant (2015), 0 descendants of its own

## Indications for use
Prevent Seal is used by dental professionals primarily in young children: * To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities; * Covering layer or "initial layer" in the fabrication of esthetically demanding composite restorations; and * For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).

Source page: https://510kreport.com/device/K122521
Methodology: https://510kreport.com/methodology