Argen Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Argen Corporation” (first 2016, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 186 days. Since 2017 the median was 164 days, against 142 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 186 |
| 2017 | 0 | — |
| 2018 | 1 | 280 |
| 2019 | 1 | 199 |
| 2020 | 1 | 130 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 66 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Argen Corporation took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| NXC | Aligner, Sequential | 2 | 2 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (5)
Most recent Argen Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242458 | ArgenZ MTZ | EIH | 2024-10-24 | 66 |
| K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | NXC | 2020-02-10 | 130 |
| K183229 | Argen Clear Aligner | NXC | 2019-06-07 | 199 |
| K172430 | ArgenIS Titanium Abutments | NHA | 2018-05-18 | 280 |
| K160248 | ArgenIS Titanium Abutments | NHA | 2016-08-05 | 186 |
Recalls
openFDA lists no recalls under a recalling firm named 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Argen Precious Metals, Inc. (217 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argen Corporation?
FDA lists 5 510(k) clearances under the applicant name “Argen Corporation” (first 2016, latest 2024), 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 Argen Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argen Corporation is 186 days. Since 2017: 164 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Argen Corporation?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 2); NXC (Aligner, Sequential, 2); EIH (Powder, Porcelain, 1).
Next steps
- See all 5 Argen Corporation clearances with predicates and recalls
- Run predicate analysis for product code NHA, 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.