# K243910: Retraxil

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, LLC
- Decided: Sep 24, 2025 after 279 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050180 (2005). 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)
- K050180: Expa-Syl, Produits Dentaires Pierre Rolland (2005) Summary page 5.
- K092384: Liquicord, Centrix, Inc. (2009)

## Indications for use
For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for * conventional or digital impressions, * cementation of temporary and permanent restorations * and the creation of Class II and V fillings.

Source page: https://510kreport.com/device/K243910
Methodology: https://510kreport.com/methodology