# K150423: Expazen

- Pathway: 510(k) (Traditional)
- Applicant: Produits Dentaires Pierre Rolland (Acteon Group)
- Decided: Jul 8, 2015 after 139 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
EXPAZEN is a paste containing aluminum chloride which is intended to be used for temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

Source page: https://510kreport.com/device/K150423
Methodology: https://510kreport.com/methodology