Presolder for Non-Precious Dental Alloys
FDA 510(k) K811563 · Williams Gold Refining Co., Inc.
510(k) numberK811563
Submission
- Device name
- Presolder for Non-Precious Dental Alloys
- Applicant
- Williams Gold Refining Co., Inc.
Mchenry, IL, US - Received
- June 4, 1981
- Decision date
- July 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041433 | Bright Gold XHEJS · Traditional | Ivoclar Vivadent, Inc. | 08/19/2004SE |
| K040436 | Simidur SuperiorEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/05/2004SE |
| K022252 | Sterngold 1, Model 1127781EJS · Abbreviated | Sterngold | 09/19/2002SE |
| K022469 | Eco E4EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 09/18/2002SE |
| K021367 | Sterngold 66, Model #1180230EJS · Abbreviated | Sterngold | 05/16/2002SE |
| K020195 | Simidur S1SEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020194 | Simidur KF PlusEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020192 | Simidur S2EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K014042 | D.Sign 84EJS · Traditional | Ivoclar Vivadent, Inc. | 02/22/2002SE |
| K013809 | D.Sign 59EJS · Traditional | Ivoclar Vivadent, Inc. | 02/07/2002SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K855182 | Alloy for Metal Crown & Bridge Yellow PD #46 & #65EJS · Traditional | 03/25/1986SE |
| K860439 | DW217 #18 Crown/Bridge & DW218 #24 Ceramic AlloysEJS · Traditional | 03/20/1986SE |
| K854738 | Spartan SolderEJH · Traditional | 03/06/1986SE |
| K852895 | Ceramic Alloy No. DW 179EJH · Traditional | 10/21/1985SE |
| K852093 | Alloy 7EJS · Traditional | 08/23/1985SE |
| K850699 | Spartan -Alloy for Porcelain Fused to MetalEJS · Traditional | 03/18/1985SE |
| K844395 | RenaissanceEJT · Traditional | 01/09/1985SE |
| K844394 | Renaissance Bonding AgentEJT · Traditional | 01/09/1985SE |
| K822419 | New Crown and Bridge Alloy No. DW196EJS · Traditional | 08/30/1982SE |
| K821510 | A TheniumEJS · Traditional | 06/09/1982SE |
Questions and answers
When was Presolder for Non-Precious Dental Alloys cleared by the FDA?
Presolder for Non-Precious Dental Alloys (K811563) received a 510(k) decision of Substantially Equivalent on July 28, 1981, 54 days after the submission was received.
What is the product code of K811563?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.