D.Sign 84
FDA 510(k) K014042 · Ivoclar Vivadent, Inc.
510(k) numberK014042
Submission
- Device name
- D.Sign 84
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- December 7, 2001
- Decision date
- February 22, 2002
- 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 |
| 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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| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | 07/01/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | 03/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | 03/05/2026SE |
| K233995 | Ivotion Base PrintEBI · Traditional | 02/23/2024SE |
| K210804 | Adhese Universal DC, Cention PrimerKLE · Traditional | 06/07/2022SE |
| K211916 | IPS e.max OneEIH · Traditional | 08/20/2021SE |
| K193193 | Telio CAD Abutment Solutions- extra systemsNHA · Abbreviated | 11/16/2020SE |
| K191453 | Cervitec FLBH · Traditional | 02/11/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | 10/08/2019SE |
| K191382 | IPS e.max CAD Abutment Solutions- extra systemsNHA · Abbreviated | 08/26/2019SE |
Questions and answers
When was D.Sign 84 cleared by the FDA?
D.Sign 84 (K014042) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 77 days after the submission was received.
What is the product code of K014042?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.