Cleared Traditional

Any-Com

K241147 · Mediclus Co., Ltd. · Dental
Sep 2024
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K241147 is an FDA 510(k) clearance for the Any-Com, 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 September 26, 2024, 154 days after receiving the submission on April 25, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K241147 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2024
Decision Date September 26, 2024
Days to Decision 154 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