Degupal

FDA 510(k) K864162 · Degussa Dental, Inc.

Substantially Equivalent

510(k) numberK864162

Submission

Device name
Degupal
Applicant
Degussa Dental, Inc.
Long Island, NY, US
Received
October 23, 1986
Decision date
November 3, 1986
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

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
K883758Albabond 60EJT · Traditional 10/12/1988SE
K883511Albabond EEJS · Traditional 10/06/1988SE
K883509Heraeus DG 63EJS · Traditional 09/22/1988SE
K883508Hera HEJT · Traditional 09/22/1988SE
K883510Degupal 4EJS · Traditional 09/15/1988SE
K883507Heraeus C SpecialEJS · Traditional 09/15/1988SE
K883512Heraeus WhiteEJS · Traditional 09/06/1988SE
K883036Palliag NF IIIEJT · Traditional 08/12/1988SE
K880033DegustarEJT · Traditional 03/07/1988SE
K871808Duceram-Metal-Ceramic Dental Porcelain SystemELL · Traditional 06/05/1987SE

Questions and answers

When was Degupal cleared by the FDA?

Degupal (K864162) received a 510(k) decision of Substantially Equivalent on November 3, 1986, 11 days after the submission was received.

What is the product code of K864162?

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