Cleared Traditional

One-Fil

K232182 · Mediclus Co., Ltd. · Dental
Jan 2024
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K232182 is an FDA 510(k) clearance for the One-Fil, 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 January 26, 2024, 186 days after receiving the submission on July 24, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K232182 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2023
Decision Date January 26, 2024
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820