Sterngold BIO-5 (1127210)
FDA 510(k) K962326 · Sterngold/Implamed
510(k) numberK962326
Submission
- Device name
- Sterngold BIO-5 (1127210)
- Applicant
- Sterngold/Implamed
Sunrise, FL, 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 EJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 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 |
| K962325 | Quasar Yellow Crown and Bridge Alloy (1122015)EJT · Traditional | 07/24/1996SE |
| K962324 | Sterngold U-Cpf Metal Alloy (1067800)EJS · 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 BIO-5 (1127210) cleared by the FDA?
Sterngold BIO-5 (1127210) (K962326) 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 K962326?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.