JP Cast 50
FDA 510(k) K011330 · Jeneric/Pentron, Inc.
510(k) numberK011330
Submission
- Device name
- JP Cast 50
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- May 2, 2001
- Decision date
- June 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K020499 | BOND-3 AdhesiveKLE · Traditional | 04/22/2002SE |
| K013543 | BOND-1 C & BKLE · Traditional | 02/22/2002SE |
| K013542 | Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional | 02/14/2002SE |
| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | 06/25/2001SE |
| K011331 | JP Cast 40EJT · Traditional | 06/22/2001SE |
| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
| K010044 | CosmicEJT · Traditional | 02/09/2001SE |
| K003683 | Avante CurelightEBZ · Traditional | 01/11/2001SE |
Questions and answers
When was JP Cast 50 cleared by the FDA?
JP Cast 50 (K011330) received a 510(k) decision of Substantially Equivalent on June 22, 2001, 51 days after the submission was received.
What is the product code of K011330?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.