Cleared Traditional

ZENEX Implant System_Short

K233163 · Izenimplant Co., Ltd. · Dental
Dec 2023
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K233163 is an FDA 510(k) clearance for the ZENEX Implant System_Short, 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 December 19, 2023, 83 days after receiving the submission on September 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K233163 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date December 19, 2023
Days to Decision 83 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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