Duo Pal 6, Order-No.: 2154
FDA 510(k) K012841 · Wieland Edelmetalle GmbH & Co.
510(k) numberK012841
Submission
- Device name
- Duo Pal 6, Order-No.: 2154
- Applicant
- Wieland Edelmetalle GmbH & Co.
Pforzheim, DE - Received
- August 23, 2001
- Decision date
- November 20, 2001
- 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 |
| 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 |
|---|---|---|
| K020347 | Agc SpeziallegierungEJT · Traditional | 04/24/2002SE |
| K012839 | Auropal, Order-No.: 2101EJT · Traditional | 12/31/2001SE |
| K012843 | Portadur P 2, Model #2031EJT · Traditional | 11/02/2001SE |
| K012835 | Porta Maximum, Model# 2066EJT · Traditional | 11/01/2001SE |
| K012834 | Porta Geo Ti Model #2004EJT · Traditional | 11/01/2001SE |
| K012831 | Bio Portadur, ORDER-NO.:2017EJT · Traditional | 11/01/2001SE |
| K012828 | Porta SMK 82, Model 2032EJS · Traditional | 11/01/2001SE |
| K012827 | Porta Aurium, Model 2067EJT · Traditional | 11/01/2001SE |
| K012826 | Bioporta G, Model 2052EJT · Traditional | 11/01/2001SE |
| K012840 | Euro 45, Order-No.: 2064EJS · Traditional | 10/23/2001SE |
Questions and answers
When was Duo Pal 6, Order-No.: 2154 cleared by the FDA?
Duo Pal 6, Order-No.: 2154 (K012841) received a 510(k) decision of Substantially Equivalent on November 20, 2001, 89 days after the submission was received.
What is the product code of K012841?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.