Solder GPW

FDA 510(k) K964713 · Gateway Alloys, Inc.

Substantially Equivalent

510(k) numberK964713

Submission

Device name
Solder GPW
Applicant
Gateway Alloys, Inc.
St. Charles, MO, US
Received
November 25, 1996
Decision date
December 16, 1996
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
K011661Concord 88EJT · Abbreviated 08/27/2001SE
K011659Gpw-SfEJT · Traditional 08/27/2001SE
K011628Concord 82EJT · Abbreviated 07/16/2001SE
K011626Concord 72EJT · Abbreviated 07/16/2001SE
K964950La Plata 28 (PM-28)EJT · Traditional 01/13/1997SE
K964949Aurora 53EJT · Traditional 01/13/1997SE
K964948Aurora 52 (PM-01)EJT · Traditional 01/13/1997SE
K964941El Dorado 40EJT · Traditional 01/13/1997SE
K964940Taos 28EJT · Traditional 01/13/1997SE
K964838Palladia 85 (PM-13)EJT · Traditional 12/20/1996SE

Questions and answers

When was Solder GPW cleared by the FDA?

Solder GPW (K964713) received a 510(k) decision of Substantially Equivalent on December 16, 1996, 21 days after the submission was received.

What is the product code of K964713?

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