Silcast (Code Name RD-0118)
FDA 510(k) K981247 · J.F. Jelenko & Co., Inc.
510(k) numberK981247
Submission
- Device name
- Silcast (Code Name RD-0118)
- Applicant
- J.F. Jelenko & Co., Inc.
Armonk, NY, US - Received
- April 6, 1998
- Decision date
- July 1, 1998
- 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 |
|---|---|---|
| K012303 | JEL-20EJS · Traditional | 08/22/2001SE |
| K002993 | HeraceramEIH · Traditional | 11/16/2000SE |
| K002645 | Jel Bios PureEJT · Traditional | 10/19/2000SE |
| K002222 | RD-2104EJT · Traditional | 08/31/2000SE |
| K001360 | SignumEBF · Traditional | 06/20/2000SE |
| K001260 | Allround 55 LFEJT · Traditional | 05/17/2000SE |
| K001196 | Jel Bios 90 (Code Name RD-2401)EJT · Traditional | 05/11/2000SE |
| K000532 | Jel 15EJS · Traditional | 04/06/2000SE |
| K000213 | Jeldent Basic LineELM · Traditional | 04/06/2000SE |
| K993152 | Jel Bios 18 (Code Name Rd- 1214)EJT · Traditional | 10/21/1999SE |
Questions and answers
When was Silcast (Code Name RD-0118) cleared by the FDA?
Silcast (Code Name RD-0118) (K981247) received a 510(k) decision of Substantially Equivalent on July 1, 1998, 86 days after the submission was received.
What is the product code of K981247?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.