GDC 3367

FDA 510(k) K920922 · Deringer-Ney, Inc.

Substantially Equivalent

510(k) numberK920922

Submission

Device name
GDC 3367
Applicant
Deringer-Ney, Inc.
Bloomfield, CT, US
Received
February 28, 1992
Decision date
May 5, 1992
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
K933178GDC 3509EJT · Traditional 10/14/1993SE
K930482Dental Casting Alloy, Modification - PF-3EJT · Traditional 03/31/1993SE
K930481Dental Casting Alloy MODIFICATION-PF-4EJT · Traditional 03/31/1993SE
K925273GDC 3445EJS · Traditional 12/21/1992SE
K920060Dental Solder AlloyEJT · Traditional 04/02/1992SE
K920887GDC-3338, Dental Solder AlloyEJS · Traditional 03/19/1992SE
K910065GDC-3200 Dental SolderEJT · Traditional 03/15/1991SE
K904695GDC-1501EJT · Traditional 01/02/1991SE
K904614GDC-1475EJT · Traditional 12/19/1990SE
K901532GDC 3084 Casting AlloyEJT · Traditional 05/02/1990SE

Questions and answers

When was GDC 3367 cleared by the FDA?

GDC 3367 (K920922) received a 510(k) decision of Substantially Equivalent on May 5, 1992, 67 days after the submission was received.

What is the product code of K920922?

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