ZENEX Implant System_Short (R-System)— 510(k) K253334
Substantially EquivalentIzenimplant Co., Ltd.
FDA 510(k) clearance K253334 for ZENEX Implant System_Short (R-System), Substantially Equivalent on 2026-03-16. Applicant: Izenimplant Co., Ltd.. Device class: 2.
Summary
Izenimplant's ZENEX Implant System_Short (R-System) is filed under DZE, root-form endosseous implants. The record doesn't list implant lengths or diameters.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Izenimplant filed from Pyeongtaek-Si, South Korea. Review took 167 calendar days (September 30, 2025 to March 16, 2026).
Clearance details
- Applicant
- Izenimplant Co., Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek-Si, KR
Recent devices under product code DZE
view allMore clearances from Izenimplant Co., Ltd.
view allAdverse 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, through . 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.