Cleared Traditional

ZENEX Implant System_R-System

K252585 · Izenimplant Co., Ltd. · Dental
Jan 2026
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K252585 is an FDA 510(k) clearance for the ZENEX Implant System_R-System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Izenimplant Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on January 8, 2026, 146 days after receiving the submission on August 15, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252585 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2025
Decision Date January 08, 2026
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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