V-Delta 450
FDA 510(k) K972683 · Metalor Dental USA Corp.
510(k) numberK972683
Submission
- Device name
- V-Delta 450
- Applicant
- Metalor Dental USA Corp.
North Attleborough, MA, US - Received
- July 17, 1997
- Decision date
- August 18, 1997
- 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 |
|---|---|---|
| K003387 | Aurofilm NPEJH · Traditional | 01/09/2001SE |
| K993475 | Aurofluid M, Alloy No. 5315EJS · Traditional | 12/09/1999SE |
| K993506 | Pagalinor 4 , Alloy No. 5440EJS · Traditional | 12/08/1999SE |
| K993505 | V-Delta Special, Alloy No. 5154EJS · Traditional | 12/08/1999SE |
| K993508 | V-Supra Plus, Alloy No. 5025EJT · Traditional | 12/06/1999SE |
| K993507 | V-Supragold, Alloy No. 5024EJT · Traditional | 12/06/1999SE |
| K993474 | Deltapal, Alloy No. 5161EJS · Traditional | 12/02/1999SE |
| K982606 | Aurofluid CPFEJT · Traditional | 10/15/1998SE |
| K973372 | Aurofilm 2000EJT · Traditional | 11/26/1997SE |
| K970045 | Solaro 33EJS · Traditional | 03/05/1997SE |
Questions and answers
When was V-Delta 450 cleared by the FDA?
V-Delta 450 (K972683) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 32 days after the submission was received.
What is the product code of K972683?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.