# K030922: Vivasens

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Oct 17, 2003 after 207 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050486: Protect Tooth Desensitizer (2005), 10 descendants of its own
- K120109: Super Seal Tooth Desensitizer (2012), 6 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own
- K241489: ReminGel (2025), 1 descendant of its own

## Indications for use
VlvascsnsCO is a film-like varnish for the treatment of hypersensitive teeth. Indications include - treatment of hypersensitive cervicals - treatment of tooth sensitivities e.g. due to bleaching procedures - treatment of sensitivities occumng after professional tooth cleaning, scaling and root-planing procedures - dentin-protection below restorative materials. It is Contraindicated if the patient has allergies to any ingredient; If the sensitivity arises from Fulpitis or other dental disease; or for Pulp-capping.

Source page: https://510kreport.com/device/K030922
Methodology: https://510kreport.com/methodology