# K171577: Smartcord, Smartcord X

- Pathway: 510(k) (Traditional)
- Applicant: Eastdent Co., Ltd.
- Decided: May 3, 2018 after 338 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 K132526 (2013). 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)
- K132526: Knit-Pak+, Premier Dental Products Co. (2013) Summary page 4.

## Most influential descendants
- K254239: CyClean Cord (2026), 0 descendants of its own

## Indications for use
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

Source page: https://510kreport.com/device/K171577
Methodology: https://510kreport.com/methodology