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Argenco Nordic

by Argen Precious Metals, Inc.

510(k) K903274

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 NumberK903274 Date6 Aug 1990ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Argenco Nordic is a gold-based noble metal alloy, classified as a dental device. It is substantially equivalent to other devices on the market.

The device is supplied by Argen Precious Metals, Inc. and has been cleared by the FDA with the clearance number K903274. The device has a product code of EJT and is regulated under regulation number 872.3060.

Other devices from Argen Precious Metals, Inc.

See all devices from Argen Precious Metals, Inc. →

Questions

AI-generated answers, 1 Oct 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 Argenco Nordic used for?

    The Argenco Nordic is used as a dental device, specifically a gold-based noble metal alloy.

  • Is the Argenco Nordic cleared by the FDA?

    Yes, the Argenco Nordic has been cleared by the FDA with clearance number K903274, indicating it is substantially equivalent to other devices on the market.

  • What is the product code for the Argenco Nordic?

    The product code for the Argenco Nordic is EJT, and it is regulated under regulation number 872.3060.