Sterngold U-Cpf Metal Alloy (1067800)
FDA 510(k) K962324 · Sterngold/Implamed
510(k) numberK962324
Submission
- Device name
- Sterngold U-Cpf Metal Alloy (1067800)
- Applicant
- Sterngold/Implamed
Attleboro, MA, US - Received
- June 17, 1996
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K984341 | Sternvantage Varnish LC, Model 221001EBI · Traditional | 01/08/1999SE |
| K984340 | Sternomega Temporary Cement Automix Ne, Model 220282/220281EMA · Abbreviated | 01/08/1999SE |
| K983786 | Sterngold Implamed Wide Platform Dental Implants and Related Prosthetics and…DZE · Special | 11/13/1998SE |
| K982692 | Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCEBF · Abbreviated | 10/22/1998SE |
| K982895 | Sternomega Compomer CementEMA · Traditional | 10/09/1998SE |
| K981516 | Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant Ha…DZE · Special | 05/11/1998SE |
| K962326 | Sterngold BIO-5 (1127210)EJT · Traditional | 07/24/1996SE |
| K962325 | Quasar Yellow Crown and Bridge Alloy (1122015)EJT · Traditional | 07/24/1996SE |
| K962304 | Sterngold BIO-4EJS · Traditional | 07/23/1996SE |
| K962303 | Sterngold CFEJT · Traditional | 07/18/1996SE |
Questions and answers
When was Sterngold U-Cpf Metal Alloy (1067800) cleared by the FDA?
Sterngold U-Cpf Metal Alloy (1067800) (K962324) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 37 days after the submission was received.
What is the product code of K962324?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.