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Argiplus Lo

by Argen Precious Metals, Inc.

510(k) K943213

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943213 Date1 Aug 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Argen Precious Metals, Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.