# K132426: Sylphar Remesense Sensitivity Relief Strips

- Pathway: 510(k) (Traditional)
- Applicant: Sylphar N.V.
- Decided: Feb 14, 2014 after 193 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: 5 generations back to K002989 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122708: Remesense for Sensitive Teeth, Sylphar N.V. (2013) Summary page 3.

## Indications for use
Syiphar Sensitivity Relief Strips are intended to aid in the relief of dentinal sensitivity resulting from cold, heat, acids, or sweets.

Source page: https://510kreport.com/device/K132426
Methodology: https://510kreport.com/methodology