# K932078: Helioseal F

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Sep 15, 1993 after 139 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K122521: Prevent Seal (2013), 1 descendant of its own
- K190339: Helioseal F Plus (2019), 0 descendants of its own
- K141717: Pacseal Pit & Fissure Sealant (2015), 0 descendants of its own

## Recalls of this device
- Oct 7, 2015 · Class II · Z-0213-2016: A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during ex

Source page: https://510kreport.com/device/K932078
Methodology: https://510kreport.com/methodology