# K131487: Fluor Protector S

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Oct 8, 2014 after 503 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
Longest line of descent: 1 generation back to K946032 (1995). 1 ancestor in all.
1 later device descends 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)
- K946032: Fluor Protector, Ivoclar North America, Inc. (1995) Summary page 4.

## Most influential descendants
- K191453: Cervitec F (2020), 0 descendants of its own

## Indications for use
- Treatment of dentinal hypersensitivity - Treatment of exposed cervicals - Treatment of sensitivity after tooth whitening

Source page: https://510kreport.com/device/K131487
Methodology: https://510kreport.com/methodology