# K130580: Retraction Paste

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Feb 25, 2014 after 357 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
For the temporary refraction 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 damn.

Source page: https://510kreport.com/device/K130580
Methodology: https://510kreport.com/methodology