Medical device manufacturer
Argen Precious Metals, Inc.
Argen Precious Metals, Inc. holds 217 FDA 510(k) clearances across 6 product codes. Median elapsed review time is 34 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 217
- Product codes
- 6
- Median review
- 34 days
- Recall records
- 0
How does FDA spell Argen Precious Metals, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Argen Precious Metals, Inc. file in?
6 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 201 | 32 days | |
| EJS | Alloy, Other Noble Metal | 9 | 66 days | |
| EJH | Alloy, Metal, Base | 4 | 44 days | |
| EFT | Cleanser, Denture, Over The Counter | 1 | 16 days | |
| EIT | Applicator, Rapid Wax, Dental | 1 | 30 days | |
| ELL | Teeth, Porcelain | 1 | 59 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Argen Precious Metals, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Argen Precious Metals, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K965216 | ARGI-SATIN OR OPTI0-STAR | ELL | 59 | |
| K961352 | 285 SL | EJT | 42 | |
| K961211 | ARGELITE 52+ | EJT | 28 | |
| K961285 | ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) | EJT | 15 | |
| K954362 | ARGISTAR 74 | EJT | 24 | |
| K954404 | AUROLITE 45 | EJT | 17 | |
| K954371 | SUREFIRE S | EJT | 18 | |
| K954368 | ARGEDENT BIO 87 PF | EJT | 22 | |
| K954367 | ARGISTAR BIO 75PF | EJT | 22 | |
| K954361 | ARGENCO 68M | EJT | 19 |
Source: openFDA device/510k · retrieved
Watch what Argen Precious Metals, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.