Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Argen Corporation with 11 510(k) clearances. The most recent is a 510(k) clearance dated Oct 24, 2024: ArgenZ MTZ.
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 |
|---|---|---|
| Oct 24, 2024 | ArgenZ MTZK242458 · EIH | 510(k) clearances |
| Feb 10, 2020 | Argen Clear Aligner, Argen Clear Aligner PremiumK192846 · NXC | 510(k) clearances |
| Jun 7, 2019 | Argen Clear AlignerK183229 · NXC | 510(k) clearances |
| Apr 12, 2019 | ArgenZ HT+K190079 · EIH | 510(k) clearances |
| Feb 8, 2019 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic ReducerK182833 · EIH | 510(k) clearances |
| May 18, 2018 | ArgenIS Titanium AbutmentsK172430 · NHA | 510(k) clearances |
| Aug 5, 2016 | ArgenIS Titanium AbutmentsK160248 · NHA | 510(k) clearances |
| Sep 16, 2015 | ArgenIS Titanium AbutmentsK143051 · NHA | 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
