# K261728: One-Fil LC

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Jul 21, 2026 after 56 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922721 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230270: 3M™ VitCal Liner/Base, 3M Espe Dental Products (2023) Summary page 5.

## Indications for use
One-Fil LC is indicated for lining and basing applications under dental restorations. One-Fil LC is also indicated for direct pulp capping.

Source page: https://510kreport.com/device/K261728
Methodology: https://510kreport.com/methodology