Cleared Traditional

Any-Com Bulk

K242713 · Mediclus Co., Ltd. · Dental
Feb 2025
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K242713 is an FDA 510(k) clearance for the Any-Com Bulk, 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 February 7, 2025, 151 days after receiving the submission on September 9, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K242713 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date February 07, 2025
Days to Decision 151 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