The Argen Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “The Argen Corporation” (first 2007, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 114 |
| 2015 | 2 | 213 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 104 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Argen Corporation took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 4 | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (6)
Most recent The Argen Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190079 | ArgenZ HT+ | EIH | 2019-04-12 | 86 |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | EIH | 2019-02-08 | 122 |
| K143051 | ArgenIS Titanium Abutments | NHA | 2015-09-16 | 328 |
| K150919 | ArgenZ Esthetic Plus | EIH | 2015-07-13 | 98 |
| K140894 | ARGEN PMMA | EBG | 2014-07-31 | 114 |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | EIH | 2007-08-15 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named The Argen Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Argen Corporation?
FDA lists 6 510(k) clearances under the applicant name “The Argen Corporation” (first 2007, latest 2019), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Argen Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Argen Corporation is 106 days.
Which FDA product codes appear under The Argen Corporation?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 4); EBG (Crown And Bridge, Temporary, Resin, 1); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 6 The Argen Corporation clearances with predicates and recalls
- Run predicate analysis for product code EIH, The Argen Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.