Olympia II
FDA 510(k) K881860 · J.F. Jelenko & Co., Inc.
510(k) numberK881860
Submission
- Device name
- Olympia II
- Applicant
- J.F. Jelenko & Co., Inc.
Armonk, NY, US - Received
- May 3, 1988
- Decision date
- June 1, 1988
- 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 |
|---|---|---|
| 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 Olympia II cleared by the FDA?
Olympia II (K881860) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 29 days after the submission was received.
What is the product code of K881860?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.