Degubond Lite

FDA 510(k) K912493 · Degussa AG

Substantially Equivalent

510(k) numberK912493

Submission

Device name
Degubond Lite
Applicant
Degussa AG
South Plainfield, NJ, US
Received
June 4, 1991
Decision date
August 20, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K973288Stabilor HNEJS · Traditional 11/19/1997SE
K972910Pors on LiteEJT · Traditional 10/14/1997SE
K960256Degudent LSEJT · Traditional 02/21/1996SE
K960226DG 88EJT · Traditional 02/14/1996SE
K960104Biocclus 4EJT · Traditional 02/06/1996SE
K955465DeguprintELW · Traditional 12/28/1995SE
K955118Degubond X-Lite PlusEJT · Traditional 12/11/1995SE
K955027Degubond X-LiteEJT · Traditional 12/01/1995SE
K953344Degubond UltraEJT · Traditional 08/25/1995SE
K951789Palliag NF IVEJT · Traditional 06/14/1995SE

Questions and answers

When was Degubond Lite cleared by the FDA?

Degubond Lite (K912493) received a 510(k) decision of Substantially Equivalent on August 20, 1991, 77 days after the submission was received.

What is the product code of K912493?

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