Cleared Traditional

ZENEX Implant System

K211090 · Izenimplant Co., Ltd. · Dental
Apr 2022
Decision
366d
Days
Class 2
Risk

About This 510(k) Submission

K211090 is an FDA 510(k) clearance for the ZENEX Implant 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 April 13, 2022, 366 days after receiving the submission on April 12, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K211090 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2021
Decision Date April 13, 2022
Days to Decision 366 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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