Cleared Traditional

ZENEX Implant System_Narrow

K230630 · Izenimplant Co., Ltd. · Dental
Jul 2023
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K230630 is an FDA 510(k) clearance for the ZENEX Implant System_Narrow, 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 July 31, 2023, 146 days after receiving the submission on March 7, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K230630 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2023
Decision Date July 31, 2023
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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