# K232182: One-Fil

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Jan 26, 2024 after 186 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960548 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170950: Well-Root ST, Vericom Co., Ltd. (2017) Summary page 5.

## Indications for use
Permanent sealing of root canal

Source page: https://510kreport.com/device/K232182
Methodology: https://510kreport.com/methodology