Orion Vesta Dental Alloy
FDA 510(k) K981001 · European Dental Imports, Inc.
510(k) numberK981001
Submission
- Device name
- Orion Vesta Dental Alloy
- Applicant
- European Dental Imports, Inc.
Durham, NH, US - Received
- March 18, 1998
- Decision date
- May 18, 1998
- 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 |
|---|---|---|
| K982129 | Antagon PorcelainEIH · Traditional | 08/04/1998SE |
| K981002 | Orion WX Dental AlloyEJS · Traditional | 05/18/1998SE |
| K981000 | Carrara Porcelain and Carrara Vincent PorcelainEIH · Traditional | 05/15/1998SE |
| K980661 | Cera E Dental AlloyEJS · Traditional | 05/01/1998SE |
| K980660 | Biogold Plus Dental AlloyEJT · Traditional | 04/27/1998SE |
| K980597 | Carrara PDF, Carrara H, Carrara REJT · Traditional | 03/09/1998SE |
Questions and answers
When was Orion Vesta Dental Alloy cleared by the FDA?
Orion Vesta Dental Alloy (K981001) received a 510(k) decision of Substantially Equivalent on May 18, 1998, 61 days after the submission was received.
What is the product code of K981001?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.