Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Izenimplant with 8 510(k) clearances. The most recent is a 510(k) clearance dated Mar 16, 2026: ZENEX Implant System_Short (R-System).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 16, 2026 | ZENEX Implant System_Short (R-System)K253334 · DZE | 510(k) clearances |
| Jan 8, 2026 | ZENEX Implant System_R-SystemK252585 · DZE | 510(k) clearances |
| Oct 30, 2024 | ZENEX Implant System_LongK240560 · DZE | 510(k) clearances |
| Jan 12, 2024 | Ti Link AbutmentK232170 · NHA | 510(k) clearances |
| Dec 19, 2023 | ZENEX Implant System_ShortK233163 · DZE | 510(k) clearances |
| Aug 24, 2023 | ZENEX FreeMilling & CCM Cast AbutmentK231557 · NHA | 510(k) clearances |
| Jul 31, 2023 | ZENEX Implant System_NarrowK230630 · DZE | 510(k) clearances |
| Apr 13, 2022 | ZENEX Implant SystemK211090 · DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
