Argiplus Lo
by Argen Precious Metals, Inc.
510(k) K943213
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943213 | Date1 Aug 1994 | 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- Withdrawn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, 24 Sep 2026
Argiplus Lo is a gold-based noble metal alloy classified as a dental device. It is intended for use in dental restorative procedures.
This device is manufactured by Argen Precious Metals, Inc. and has received FDA 510(k) clearance under K943213.
Other devices from Argen Precious Metals, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the intended use of Argiplus Lo?
Argiplus Lo is a gold-based noble metal alloy specifically designed for use in dental restorative procedures to support clinical dental work.
Who is the manufacturer of this dental alloy?
This device is manufactured by Argen Precious Metals, Inc., located in San Diego, California.
Has this device received regulatory clearance?
Yes, Argiplus Lo has received FDA 510(k) clearance under K943213, confirming it has been found substantially equivalent to predicate devices for its intended use.