Simidur Superior
FDA 510(k) K040436 · Wieland Dental + Technik GmbH & Co. KG
510(k) numberK040436
Submission
- Device name
- Simidur Superior
- Applicant
- Wieland Dental + Technik GmbH & Co. KG
Pforzheim, DE - Received
- February 19, 2004
- Decision date
- March 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K014082 | D.Sign 53, Model NA1012204EJS · Traditional | Ivoclar Vivadent, Inc. | 01/30/2002SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152118 | Zenostar MT, Zenostar Color LiquidsEIH · Traditional | 12/16/2015SE |
| K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidEBI · Traditional | 08/13/2015SE |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZrEIH · Traditional | 01/05/2015SE |
| K130184 | ZenoluxEIH · Abbreviated | 05/24/2013SE |
| K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZREIH · Special | 10/17/2011SE |
| K103773 | Zenoflex DimensionEIH · Abbreviated | 03/16/2011SE |
| K103494 | Zenostar Magic GlazeEIH · Traditional | 02/16/2011SE |
| K082257 | Zeno Ai Eco DiscEIH · Traditional | 09/18/2008SE |
| K080182 | Zeno Pmma DiscEBG · Traditional | 04/08/2008SE |
| K073108 | Zeno ZR DiscEIH · Special | 11/21/2007SE |
Questions and answers
When was Simidur Superior cleared by the FDA?
Simidur Superior (K040436) received a 510(k) decision of Substantially Equivalent on March 5, 2004, 15 days after the submission was received.
What is the product code of K040436?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.