# K162662: GingiDent Gingival Retraction Paste

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Oct 20, 2017 after 389 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K253797: One-Stop (2026), 0 descendants of its own

## Indications for use
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.

Source page: https://510kreport.com/device/K162662
Methodology: https://510kreport.com/methodology