Argedent 74 Dental Alloy For Porcelain Appli
by Argen Precious Metals, Inc.
510(k) K892335
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892335 | Date31 May 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Argedent 74 is a gold‑based noble metal alloy classified as a dental alloy. It is formulated for use in porcelain‑fused‑to‑metal restorations, providing the strength and esthetic compatibility required for fixed prosthetic applications.
The alloy is marketed by Argen Precious Metals, Inc. of San Diego, California, and has received FDA 510(k) clearance (K892335) under product code EJT, class II with special controls. It is supplied as a castable material for dental laboratory use and is stored according to the manufacturer’s specifications.
Other devices from Argen Precious Metals, Inc.
Questions
AI-generated answers, 22 Sep 2026
What clinical applications is ARGEDENT 74 intended for?
ARGEDENT 74 is formulated specifically for porcelain‑fused‑to‑metal (PFM) fixed prosthetic restorations. The gold‑based composition provides the strength and esthetic compatibility needed to support porcelain layering on metal substructures in crowns and bridges.
How is the alloy provided to dental laboratories?
The alloy is supplied as a castable material, meaning it is delivered in a form that can be melted and poured into molds by the dental lab. This allows technicians to fabricate custom PFM frameworks that match each patient’s anatomy.
Is ARGEDENT 74 a sterile, single‑use product?
ARGEDENT 74 is not marketed as a sterile, single‑use item. It is a bulk alloy intended for casting in a controlled laboratory environment, where standard infection‑control practices are applied during processing.
What regulatory pathway did ARGEDENT 74 follow?
The device received FDA 510(k) clearance (K892335) under product code EJT, class II with special controls. This indicates it was found substantially equivalent to a legally marketed predicate device and is cleared for its intended dental alloy use.