Cleared Traditional

ZENEX Implant System_Long

K240560 · Izenimplant Co., Ltd. · Dental
Oct 2024
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K240560 is an FDA 510(k) clearance for the ZENEX Implant System_Long, 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 October 30, 2024, 244 days after receiving the submission on February 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K240560 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2024
Decision Date October 30, 2024
Days to Decision 244 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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