PA-393 Gold Based/Precious Metal Alloys Clin Use
FDA 510(k) K912194 · Jelenko Co.
510(k) numberK912194
Submission
- Device name
- PA-393 Gold Based/Precious Metal Alloys Clin Use
- Applicant
- Jelenko Co.
Armonk, NY, US - Received
- May 17, 1991
- Decision date
- July 30, 1991
- 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 |
|---|---|---|
| K010416 | Heraceram 75EJT · Traditional | 03/08/2001SE |
| K003603 | Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond…EJT · Traditional | 01/10/2001SE |
| K984164 | Jelbond NPEJH · Traditional | 12/29/1998SE |
| K964158 | JEL-40 (Code Name RD-0430)EJT · Traditional | 12/13/1996SE |
| K930762 | SuperstarEJT · Traditional | 03/31/1993SE |
| K912195 | PA-396 Gold Based/Precious Metal Alloys Clin UseEJS · Traditional | 07/30/1991SE |
| K896915 | Palladium Based Dental Alloy for Porcelain-MetalEJT · Traditional | 04/30/1990SE |
| K894391 | PVS Dual Cure Veneer Bonding KitKLE · Traditional | 09/19/1989SE |
| K893688 | High Noble, Type III Dental Casting AlloyEJT · Traditional | 08/23/1989SE |
| K885302 | Gold/Palladium Based Dental AlloyEJT · Traditional | 02/13/1989SE |
Questions and answers
When was PA-393 Gold Based/Precious Metal Alloys Clin Use cleared by the FDA?
PA-393 Gold Based/Precious Metal Alloys Clin Use (K912194) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 74 days after the submission was received.
What is the product code of K912194?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.