Cleared Special

Any-Com Flow

K250823 · Mediclus Co., Ltd. · Dental
Apr 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K250823 is an FDA 510(k) clearance for the Any-Com 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 April 14, 2025, 27 days after receiving the submission on March 18, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K250823 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2025
Decision Date April 14, 2025
Days to Decision 27 days
Submission Type Special
Review Panel Dental (DE)
Summary —

Device Classification

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