Aurecast Bio 69PF
FDA 510(k) K972940 · Aurex Precious Metal Industries (Pty)Ltd
510(k) numberK972940
Submission
- Device name
- Aurecast Bio 69PF
- Applicant
- Aurex Precious Metal Industries (Pty)Ltd
Edenvale, ZA - Received
- June 20, 1997
- Decision date
- August 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K972946 | Aurelux 77EJT · Traditional | 12/19/1997SE |
| K972945 | Aurenorm 68EJS · Traditional | 11/26/1997SE |
| K972949 | Aurelux Bio Y85PFEJT · Traditional | 09/18/1997SE |
| K972943 | Aurecast 92EJT · Traditional | 09/16/1997SE |
| K972956 | Palceram 82SFEJT · Traditional | 09/05/1997SE |
| K972955 | Palceram 56EJT · Traditional | 09/05/1997SE |
| K972954 | Palaurex 78EJT · Traditional | 09/05/1997SE |
| K972953 | Palaurex 76KFEJT · Traditional | 09/05/1997SE |
| K972952 | Aurebond 51EJT · Traditional | 09/05/1997SE |
| K972951 | Hipallaur 51EJT · Traditional | 09/05/1997SE |
Questions and answers
When was Aurecast Bio 69PF cleared by the FDA?
Aurecast Bio 69PF (K972940) received a 510(k) decision of Substantially Equivalent on August 26, 1997, 67 days after the submission was received.
What is the product code of K972940?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.