# K082594: Remesense

- Pathway: 510(k) (Traditional)
- Applicant: Remedent NV
- Decided: Mar 19, 2009 after 192 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 K931096 (1993). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061438: Ultraez Desensitizing Gel, Ultradent Products, Inc. (2007) Summary page 1.
- K041680: Orajel Advanced Tooth Desensitizer, Del Pharmaceuticals, Inc. (2004) Summary page 1.
- K983477: Super Seal, Phoenix Dental, Inc. (1998) Summary page 1.
- K073061: The Proxivent Kit, Coll Partners, Ltd. (2008) Summary page 1.

## Most influential descendants
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K132426: Sylphar Remesense Sensitivity Relief Strips (2014), 0 descendants of its own

## Indications for use
Remesense is indicated for use as a tooth desensitizer.

Source page: https://510kreport.com/device/K082594
Methodology: https://510kreport.com/methodology