Gold-Platinum Based Casting Alloy
FDA 510(k) K926147 · Jeneric/Pentron, Inc.
510(k) numberK926147
Submission
- Device name
- Gold-Platinum Based Casting Alloy
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- December 7, 1992
- Decision date
- May 27, 1993
- 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 |
|---|---|---|
| K020499 | BOND-3 AdhesiveKLE · Traditional | 04/22/2002SE |
| K013543 | BOND-1 C & BKLE · Traditional | 02/22/2002SE |
| K013542 | Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional | 02/14/2002SE |
| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | 06/25/2001SE |
| K011331 | JP Cast 40EJT · Traditional | 06/22/2001SE |
| K011330 | JP Cast 50EJT · Traditional | 06/22/2001SE |
| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
| K010044 | CosmicEJT · Traditional | 02/09/2001SE |
Questions and answers
When was Gold-Platinum Based Casting Alloy cleared by the FDA?
Gold-Platinum Based Casting Alloy (K926147) received a 510(k) decision of Substantially Equivalent on May 27, 1993, 171 days after the submission was received.
What is the product code of K926147?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.