GDC-1629 a Casting Alloy
FDA 510(k) K850101 · Deringer-Ney, Inc.
510(k) numberK850101
Submission
- Device name
- GDC-1629 a Casting Alloy
- Applicant
- Deringer-Ney, Inc.
Bloomfield, CT, US - Received
- January 11, 1985
- Decision date
- February 8, 1985
- 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 |
|---|---|---|
| K933178 | GDC 3509EJT · Traditional | 10/14/1993SE |
| K930482 | Dental Casting Alloy, Modification - PF-3EJT · Traditional | 03/31/1993SE |
| K930481 | Dental Casting Alloy MODIFICATION-PF-4EJT · Traditional | 03/31/1993SE |
| K925273 | GDC 3445EJS · Traditional | 12/21/1992SE |
| K920922 | GDC 3367EJS · Traditional | 05/05/1992SE |
| K920060 | Dental Solder AlloyEJT · Traditional | 04/02/1992SE |
| K920887 | GDC-3338, Dental Solder AlloyEJS · Traditional | 03/19/1992SE |
| K910065 | GDC-3200 Dental SolderEJT · Traditional | 03/15/1991SE |
| K904695 | GDC-1501EJT · Traditional | 01/02/1991SE |
| K904614 | GDC-1475EJT · Traditional | 12/19/1990SE |
Questions and answers
When was GDC-1629 a Casting Alloy cleared by the FDA?
GDC-1629 a Casting Alloy (K850101) received a 510(k) decision of Substantially Equivalent on February 8, 1985, 28 days after the submission was received.
What is the product code of K850101?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.