ZENEX Implant System_R-System— 510(k) K252585

Name: FDA 510(k) clearance K252585
Creator: U.S. Food and Drug Administration
Published: 2026-01-08

Substantially Equivalent

Izenimplant Co., Ltd.

FDA 510(k) clearance K252585 for ZENEX Implant System_R-System, Substantially Equivalent on 2026-01-08. Applicant: Izenimplant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Izenimplant Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2025-08-15
Decision date: 2026-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Izenimplant Co., Ltd.

view all

K253334 — ZENEX Implant System_Short (R-System)2026-03-16
K240560 — ZENEX Implant System_Long2024-10-30
K232170 — Ti Link Abutment2024-01-12
K233163 — ZENEX Implant System_Short2023-12-19
K231557 — ZENEX FreeMilling & CCM Cast Abutment2023-08-24

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.