Cleared Traditional

Any-Paste

K253167 · Mediclus Co., Ltd. · Dental
Jan 2026
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K253167 is an FDA 510(k) clearance for the Any-Paste, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on January 12, 2026, 108 days after receiving the submission on September 26, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K253167 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date January 12, 2026
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820