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One-Fil Putty Injectable

by MEDICLUS Co., Ltd.

510(k) K251884

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251884↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK251884 Date22 Aug 2025ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251884 decided 22 Aug 2025 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
KIF
Device class
Class II
Regulation
21 CFR Part 872.3820
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K251884

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K251884
UDI-DISize and differences
One-Fil Putty Injectable 509-1 One-Fil Putty Injectable
MEDICLUS Co., Ltd.
EC2501001 / 509-1 One-Fil Putty Injectable08809518345106
Weight 0.5 g
On the market

Similar devices

Other devices filed under FDA product code KIF (Resin, Root Canal Filling).

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