# K041023: Stay-Put Impregnated

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent GmbH & Co. KG
- Decided: Jun 15, 2004 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Ultrapak E: named in the summary without a submission number

## Most influential descendants
- K091380: Cordcap (2009), 0 descendants of its own

## Indications for use
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.

Source page: https://510kreport.com/device/K041023
Methodology: https://510kreport.com/methodology