# K111348: RE / Stasis (TM) Gingival Retraction Paste

- Pathway: 510(k) (Traditional)
- Applicant: Centrix, Inc.
- Decided: Jul 22, 2011 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Re/StasisTM is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.

Source page: https://510kreport.com/device/K111348
Methodology: https://510kreport.com/methodology