Cleared Traditional

Once-Fil Flow

K251283 · Mediclus Co., Ltd. · Dental
Jun 2025
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K251283 is an FDA 510(k) clearance for the Once-Fil Flow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on June 6, 2025, 42 days after receiving the submission on April 25, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K251283 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2025
Decision Date June 06, 2025
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690