# K053329: Korlex-GR Gingival Retraction Paste

- Pathway: 510(k) (Traditional)
- Applicant: Biotech One, Inc.
- Decided: Feb 15, 2006 after 76 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Korlex-GRfM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.

Source page: https://510kreport.com/device/K053329
Methodology: https://510kreport.com/methodology