Gold/Palladium Based Dental Alloy
FDA 510(k) K885302 · Jelenko Co.
510(k) numberK885302
Submission
- Device name
- Gold/Palladium Based Dental Alloy
- Applicant
- Jelenko Co.
Armonk, NY, US - Received
- December 27, 1988
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 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 |
| K912194 | PA-393 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 |
Questions and answers
When was Gold/Palladium Based Dental Alloy cleared by the FDA?
Gold/Palladium Based Dental Alloy (K885302) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 48 days after the submission was received.
What is the product code of K885302?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.