Argenco III

FDA 510(k) K903009 · Argen Precious Metals, Inc.

Substantially Equivalent

510(k) numberK903009

Submission

Device name
Argenco III
Applicant
Argen Precious Metals, Inc.
San Diego, CA, US
Received
July 9, 1990
Decision date
August 13, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJS – Alloy, Other Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

Other 510(k)s with product code EJS

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K041433Bright Gold XHEJS · Traditional Ivoclar Vivadent, Inc.08/19/2004SE
K040436Simidur SuperiorEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/05/2004SE
K022252Sterngold 1, Model 1127781EJS · Abbreviated Sterngold09/19/2002SE
K022469Eco E4EJS · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K021367Sterngold 66, Model #1180230EJS · Abbreviated Sterngold05/16/2002SE
K020195Simidur S1SEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020194Simidur KF PlusEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020192Simidur S2EJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K014042D.Sign 84EJS · Traditional Ivoclar Vivadent, Inc.02/22/2002SE
K013809D.Sign 59EJS · Traditional Ivoclar Vivadent, Inc.02/07/2002SE

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K961211Argelite 52+EJT · Traditional 04/25/1996SE
K961285Argedent 40(GOLD-PALLADIUM-SILVER Alloy for Porcelain Application)EJT · Traditional 04/18/1996SE
K954362Argistar 74EJT · Traditional 10/12/1995SE
K954404Aurolite 45EJT · Traditional 10/07/1995SE
K954371Surefire SEJT · Traditional 10/07/1995SE
K954368Argedent Bio 87 PFEJT · Traditional 10/07/1995SE
K954367Argistar Bio 75PFEJT · Traditional 10/07/1995SE
K954361Argenco 68MEJT · Traditional 10/07/1995SE

Questions and answers

When was Argenco III cleared by the FDA?

Argenco III (K903009) received a 510(k) decision of Substantially Equivalent on August 13, 1990, 35 days after the submission was received.

What is the product code of K903009?

The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.