500 SL (Silhouette Line) Dental Casting Alloys
FDA 510(k) K895062 · Leach and Dillon Co., Inc.
510(k) numberK895062
Submission
- Device name
- 500 SL (Silhouette Line) Dental Casting Alloys
- Applicant
- Leach and Dillon Co., Inc.
Mansfield, MA, US - Received
- August 8, 1989
- Decision date
- December 18, 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 |
|---|---|---|
| K903538 | Wiron 99 Dental Casting AlloyEJH · Traditional | 03/15/1991SE |
| K903537 | 250 SL Dental Casting AlloyEJT · Traditional | 10/24/1990SE |
| K895059 | High Fusing Yellow Ceramic SolderEJT · Traditional | 10/05/1990SE |
| K895058 | High Fusing White Ceramic SolderEJT · Traditional | 10/05/1990SE |
| K903484 | Select 20, Dental AlloyEJT · Traditional | 09/14/1990SE |
| K902373 | 200 Silhouette Line (SL) Ceramic SolderEJT · Traditional | 06/28/1990SE |
| K902372 | Silver-Free Ceramic Solder (SFCS)EJT · Traditional | 06/28/1990SE |
| K895888 | Silhouette PorcelainEIH · Traditional | 04/10/1990SE |
| K895889 | Shake N' Spray (W/Silhouette Porcelain)EIH · Traditional | 04/04/1990SE |
| K895066 | Monogram IVEJT · Traditional | 02/14/1990SE |
Questions and answers
When was 500 SL (Silhouette Line) Dental Casting Alloys cleared by the FDA?
500 SL (Silhouette Line) Dental Casting Alloys (K895062) received a 510(k) decision of Substantially Equivalent on December 18, 1989, 132 days after the submission was received.
What is the product code of K895062?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.