Cleared Special

One-Fil Putty Injectable

K251884 · Mediclus Co., Ltd. · Dental

Aug 2025

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K251884 is an FDA 510(k) clearance for the One-Fil Putty Injectable, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on August 22, 2025, 63 days after receiving the submission on June 20, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K251884 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	August 22, 2025
Days to Decision	63 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF