Argen Precious Metals, Inc.: FDA clearances and approvals
Argen Precious Metals, Inc. has 217 FDA 510(k) clearances (first 1989, latest 1997), across 6 product codes in 1 review panel. Median 510(k) review time: 34 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 201 | 201 |
| EJS | Alloy, Other Noble Metal | 9 | 9 |
| EJH | Alloy, Metal, Base | 4 | 4 |
| EFT | Cleanser, Denture, Over The Counter | 1 | 1 |
| EIT | Applicator, Rapid Wax, Dental | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
Review panels
- Dental (217)
Most recent Argen Precious Metals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965216 | ARGI-SATIN OR OPTI0-STAR | ELL | 1997-02-27 | 59 |
| K961352 | 285 SL | EJT | 1996-05-20 | 42 |
| K961211 | ARGELITE 52+ | EJT | 1996-04-25 | 28 |
| K961285 | ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) | EJT | 1996-04-18 | 15 |
| K954362 | ARGISTAR 74 | EJT | 1995-10-12 | 24 |
| K954404 | AUROLITE 45 | EJT | 1995-10-07 | 17 |
| K954371 | SUREFIRE S | EJT | 1995-10-07 | 18 |
| K954368 | ARGEDENT BIO 87 PF | EJT | 1995-10-07 | 22 |
| K954367 | ARGISTAR BIO 75PF | EJT | 1995-10-07 | 22 |
| K954361 | ARGENCO 68M | EJT | 1995-10-07 | 19 |
207 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Argen Precious Metals, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Argen Precious Metals, Inc. have?
Argen Precious Metals, Inc. has 217 FDA 510(k) clearances (first 1989, latest 1997), across 6 product codes in 1 review panel.
How long does FDA take to clear Argen Precious Metals, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Argen Precious Metals, Inc.'s cleared 510(k)s is 34 days.
What devices does Argen Precious Metals, Inc. make?
Its most frequent FDA product codes are EJT (Alloy, Gold-Based Noble Metal, 201); EJS (Alloy, Other Noble Metal, 9); EJH (Alloy, Metal, Base, 4).
Has Argen Precious Metals, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Argen Precious Metals, Inc. Related entities may recall under other names.
Next steps
- See all 217 Argen Precious Metals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Argen Precious Metals, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.