# One-Fil Putty Injectable

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/one-fil-putty-injectable-kif>
- Manufacturer: [MEDICLUS Co., Ltd.](https://devicerts.com/manufacturers/mediclus-co-ltd) (South Korea)
- Device class: Class II (US FDA)
- FDA product code: KIF

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The One-Fil Putty Injectable is a premixed bioceramic cement designed for permanent root canal filling. It is formulated with a tricalcium silicate composition that sets and hardens in the presence of moisture, providing a durable seal within the root canal system.

This device is supplied as a single-use, non-sterile material intended for dental use under aseptic conditions. It is classified as a Class II medical device under FDA regulations (product code KIF) and has received FDA 510(k) clearance. The material is packaged for direct application in endodontic procedures and is not intended for MRI use.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K251884 · decision 2025-08-22 · decision SESE · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K251884 [FDA 510(k)]
- FDA product code: KIF [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 872.3820 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: One-Fil Putty Injectable, MEDICLUS Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/one-fil-putty-injectable-kif (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-12
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/one-fil-putty-injectable-kif.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/one-fil-putty-injectable-kif
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.