# K190339: Helioseal F Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jul 29, 2019 after 165 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
Helioseal F Plus is used to seal fissures, pits and foramina caeca.

Source page: https://510kreport.com/device/K190339
Methodology: https://510kreport.com/methodology