# K191453: Cervitec F

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Feb 11, 2020 after 256 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: 2 generations back to K946032 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131487: Fluor Protector S, Ivoclar Vivadent, AG (2014) Summary page 4.

## Indications for use
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Source page: https://510kreport.com/device/K191453
Methodology: https://510kreport.com/methodology