# K253797: One-Stop

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Feb 27, 2026 after 91 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: 2 generations 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)
- K162662: GingiDent Gingival Retraction Paste, Pac-Dent International, Inc. (2017) Summary page 5.

## Indications for use
One-Stop is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation, and cavity preparation.

Source page: https://510kreport.com/device/K253797
Methodology: https://510kreport.com/methodology