# K113839: Retract Gingival Retraction/Hemostatic Paste

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Apr 12, 2012 after 106 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083695: Traxodent, Premier Dental Products Co. (2009) Summary page 1.
- K050180: Expa-Syl, Produits Dentaires Pierre Rolland (2005) Summary page 1.
- K093711: Racegel, Septodont (2010) Summary page 1.

## Indications for use
RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

Source page: https://510kreport.com/device/K113839
Methodology: https://510kreport.com/methodology