# K050180: Expa-Syl

- Pathway: 510(k) (Traditional)
- Applicant: Produits Dentaires Pierre Rolland
- Decided: Feb 11, 2005 after 16 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.
8 later devices descend from it; 7 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stay-put Impregnated: named in the summary without a submission number
- (no number) Ultrapak E: named in the summary without a submission number

## Most influential descendants
- K082116: Hemostasyl Paste (2008), 2 descendants of its own
- K162662: GingiDent Gingival Retraction Paste (2017), 1 descendant of its own
- K253797: One-Stop (2026), 0 descendants of its own
- K243910: Retraxil (2025), 0 descendants of its own
- K130580: Retraction Paste (2014), 0 descendants of its own

## Indications for use
Expa-syl is a paste containing aluminum chloride which is intended to be used for the 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/K050180
Methodology: https://510kreport.com/methodology