Will-Ceram W-3

FDA 510(k) K771596 · Williams Gold Refining Co., Inc.

Substantially Equivalent

510(k) numberK771596

Submission

Device name
Will-Ceram W-3
Applicant
Williams Gold Refining Co., Inc.
Mchenry, IL, US
Received
August 19, 1977
Decision date
August 26, 1977
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
K855182Alloy for Metal Crown & Bridge Yellow PD #46 & #65EJS · Traditional 03/25/1986SE
K860439DW217 #18 Crown/Bridge & DW218 #24 Ceramic AlloysEJS · Traditional 03/20/1986SE
K854738Spartan SolderEJH · Traditional 03/06/1986SE
K852895Ceramic Alloy No. DW 179EJH · Traditional 10/21/1985SE
K852093Alloy 7EJS · Traditional 08/23/1985SE
K850699Spartan -Alloy for Porcelain Fused to MetalEJS · Traditional 03/18/1985SE
K844395RenaissanceEJT · Traditional 01/09/1985SE
K844394Renaissance Bonding AgentEJT · Traditional 01/09/1985SE
K822419New Crown and Bridge Alloy No. DW196EJS · Traditional 08/30/1982SE
K821510A TheniumEJS · Traditional 06/09/1982SE

Questions and answers

When was Will-Ceram W-3 cleared by the FDA?

Will-Ceram W-3 (K771596) received a 510(k) decision of Substantially Equivalent on August 26, 1977, 7 days after the submission was received.

What is the product code of K771596?

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