# K082116: Hemostasyl Paste

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Dec 17, 2008 after 142 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). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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 1.

## Most influential descendants
- K111978: Sulcus Blue (2011), 0 descendants of its own
- K093721: COSP2 (2010), 0 descendants of its own

## Indications for use
Hemostasyl Paste achieves its hemostatic effect in the gingival sulcus by physical and mechanical means during dental procedures such as dental impressions, scaling, seating of temporary and permanent restorations, and placement of a rubber dam.

Source page: https://510kreport.com/device/K082116
Methodology: https://510kreport.com/methodology