D-Sign III (R&D Project DW264#7)
FDA 510(k) K990077 · Ivoclar North America, Inc.
510(k) numberK990077
Submission
- Device name
- D-Sign III (R&D Project DW264#7)
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- January 11, 1999
- Decision date
- February 12, 1999
- 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 |
|---|---|---|
| K012174 | Eris Layering MaterialsEIH · Traditional | 08/27/2001SE |
| K011491 | Helioseal Clear ChromaEBC · Traditional | 08/16/2001SE |
| K011492 | In Ten-SEBF · Traditional | 07/05/2001SE |
| K011490 | Modification to ExciteKLE · Traditional | 06/27/2001SE |
| K011023 | D.Sign 96EJT · Traditional | 05/02/2001SE |
| K011022 | Biouniversal PDFEJT · Traditional | 05/02/2001SE |
| K010381 | D.Sign 30EJH · Traditional | 03/06/2001SE |
| K010250 | Tetric Ceram HBEBF · Traditional | 02/28/2001SE |
| K003293 | Excite DSCKLE · Traditional | 02/06/2001SE |
| K003407 | Systemp.Desensitizer (Vivadent.Desensitizer)EMA · Traditional | 01/26/2001SE |
Questions and answers
When was D-Sign III (R&D Project DW264#7) cleared by the FDA?
D-Sign III (R&D Project DW264#7) (K990077) received a 510(k) decision of Substantially Equivalent on February 12, 1999, 32 days after the submission was received.
What is the product code of K990077?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.