The Argen Corporation
San Diego, CA, US
THE ARGEN CORPORATION appears in FDA device records in San Diego, CA. FDA records list 11 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for The Argen Corporation between 2007 and 2024. The busiest year on record is 2019, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242458 | ArgenZ MTZ | EIH | Substantially Equivalent | |
| K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | NXC | Substantially Equivalent | |
| K183229 | Argen Clear Aligner | NXC | Substantially Equivalent | |
| K190079 | ArgenZ HT+ | EIH | Substantially Equivalent | |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | EIH | Substantially Equivalent | |
| K172430 | ArgenIS Titanium Abutments | NHA | Substantially Equivalent | |
| K160248 | ArgenIS Titanium Abutments | NHA | Substantially Equivalent | |
| K143051 | ArgenIS Titanium Abutments | NHA | Substantially Equivalent | |
| K150919 | ArgenZ Esthetic Plus | EIH | Substantially Equivalent | |
| K140894 | ARGEN PMMA | EBG | Substantially Equivalent | |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2433919 | 2433919 | THE ARGEN CORPORATION | 5855 Oberlin Dr, SAN DIEGO, CA 92121 US | 2026 | |
| 3013551048 | 3013551048 | The Argen Corporation | 8515 Miralani Drive, San Diego, CA 92126 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- LYUAccessory, Surgical Apparel
- NXCAligner, Sequential
- EJTAlloy, Gold-Based Noble Metal
- EJHAlloy, Metal, Base
- EJSAlloy, Other Noble Metal
- KXFApplicator, Absorbent Tipped, Non-Sterile
- EBGCrown And Bridge, Temporary, Resin
- EBHMaterial, Impression Tray, Resin
- MQCMouthguard, Prescription
- KMYPositioner, Tooth, Preformed
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain