# K122708: Remesense for Sensitive Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Sylphar N.V.
- Decided: Jan 14, 2013 after 132 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: 4 generations back to K002989 (2000). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082594: Remesense, Remedent NV (2009) Summary page 2.
- K120176: Senzzzzz Away, Centrix, Inc. (2012) Summary page 3.

## Most influential descendants
- K132426: Sylphar Remesense Sensitivity Relief Strips (2014), 0 descendants of its own

## Indications for use
Remnesense for Sensitive Teeth is intended for use as a tooth desensitizer.

Source page: https://510kreport.com/device/K122708
Methodology: https://510kreport.com/methodology