# K251884: One-Fil Putty Injectable

- Pathway: 510(k) (Special)
- Applicant: Mediclus Co., Ltd.
- Decided: Aug 22, 2025 after 63 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: 10 generations back to K990131 (1999). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243353: One-Fil Putty, Mediclus Co., Ltd. (2025) Summary page 5.

## Indications for use
1. Furcation or root perforation treatment via canal 2. Furcation or root perforation treatment via surgical 3. Internal reabsorption treatment via canal or surgical 4. External reabsorption treatment 5. Retrofilling in parendodontic surgery 6. Direct and Indirect pulp capping 7. Apexification 8. Apexogenesis and Pulpotomy

Source page: https://510kreport.com/device/K251884
Methodology: https://510kreport.com/methodology