# K946032: Fluor Protector

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Mar 7, 1995 after 88 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K131487: Fluor Protector S (2014), 1 descendant of its own
- K191453: Cervitec F (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K946032
Methodology: https://510kreport.com/methodology