Simidur S2
FDA 510(k) K020192 · Wieland Dental + Technik GmbH & Co. KG
510(k) numberK020192
Submission
- Device name
- Simidur S2
- Applicant
- Wieland Dental + Technik GmbH & Co. KG
Pforzheim, DE - Received
- January 22, 2002
- Decision date
- March 15, 2002
- 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 |
| 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 |
| 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 |
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| K152118 | Zenostar MT, Zenostar Color LiquidsEIH · Traditional | 12/16/2015SE |
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| 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 S2 cleared by the FDA?
Simidur S2 (K020192) received a 510(k) decision of Substantially Equivalent on March 15, 2002, 52 days after the submission was received.
What is the product code of K020192?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.