Cleared Traditional

One-Fil Putty

K243353 · Mediclus Co., Ltd. · Dental

Mar 2025

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K243353 is an FDA 510(k) clearance for the One-Fil Putty, 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 March 14, 2025, 136 days after receiving the submission on October 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K243353 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2024
Decision Date	March 14, 2025
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF