Standard S1

FDA 510(k) K912303 · Metalor Dental USA Corp.

Substantially Equivalent

510(k) numberK912303

Submission

Device name
Standard S1
Applicant
Metalor Dental USA Corp.
Rockville Centre, NY, US
Received
May 21, 1991
Decision date
June 26, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

510(k)DeviceApplicantDecision
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

More from Ivoclar Vivadent, Inc.

510(k)DeviceDecision
K003387Aurofilm NPEJH · Traditional 01/09/2001SE
K993475Aurofluid M, Alloy No. 5315EJS · Traditional 12/09/1999SE
K993506Pagalinor 4 , Alloy No. 5440EJS · Traditional 12/08/1999SE
K993505V-Delta Special, Alloy No. 5154EJS · Traditional 12/08/1999SE
K993508V-Supra Plus, Alloy No. 5025EJT · Traditional 12/06/1999SE
K993507V-Supragold, Alloy No. 5024EJT · Traditional 12/06/1999SE
K993474Deltapal, Alloy No. 5161EJS · Traditional 12/02/1999SE
K982606Aurofluid CPFEJT · Traditional 10/15/1998SE
K973372Aurofilm 2000EJT · Traditional 11/26/1997SE
K972683V-Delta 450EJS · Traditional 08/18/1997SE

Questions and answers

When was Standard S1 cleared by the FDA?

Standard S1 (K912303) received a 510(k) decision of Substantially Equivalent on June 26, 1991, 36 days after the submission was received.

What is the product code of K912303?

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