# K243353: One-Fil Putty

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Mar 14, 2025 after 136 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: 9 generations back to K990131 (1999). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180185: Bio-C Repair, Angelus Industria DE Produtos Odontologicos S/A (2018) Summary page 5.

## Most influential descendants
- K251884: One-Fil Putty Injectable (2025), 0 descendants of its own

## Indications for use
Furcation or root perforation treatment via canal Furcation or root perforation treatment via surgical Internal reabsorption treatment via canal or surgical External reabsorption treatment Retrofilling in parendodontic surgery Direct and indirect pulp capping Apexification Apexogenesis and Pulpotomy

Source page: https://510kreport.com/device/K243353
Methodology: https://510kreport.com/methodology