K253334
- 510(k) number
- K253334
- Device name
- ZENEX Implant System_Short (R-System)
- Applicant
- Izenimplant Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2026-03-16
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253334.pdf
Official FDA record: K253334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.