Cleared Traditional

Any-Core

K252465 · Mediclus Co., Ltd. · Dental
Dec 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K252465 is an FDA 510(k) clearance for the Any-Core, 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 December 5, 2025, 121 days after receiving the submission on August 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K252465 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2025
Decision Date December 05, 2025
Days to Decision 121 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

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