Aurecast Super Inlay

FDA 510(k) K001478 · Aurex SA (Pty) , Ltd.

Substantially Equivalent

510(k) numberK001478

Submission

Device name
Aurecast Super Inlay
Applicant
Aurex SA (Pty) , Ltd.
Edenvale, Gauteng, ZA
Received
May 11, 2000
Decision date
June 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

Other 510(k)s with product code EJT

510(k)DeviceApplicantDecision
K052463Prometal HN86EJT · Traditional Prometal Technologies10/14/2005SE
K041378Bio 60EJT · Traditional Kodent, Inc.08/02/2004SE
K040672Porta ReflexEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/27/2004SE
K040524Porta Solder 1090 WEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/20/2004SE
K040043NDX-40 AlloyEJT · Traditional Heraeus Kulzer, Inc.03/03/2004SE
K034049Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional Heraeus Kulzer,GmbH03/01/2004SE
K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/13/2003SE
K033435E-Sarang 86, DM78, DM55EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032320Appollo 3 AlloyEJT · Traditional Dentsply International10/01/2003SE

More from Dentsply International

510(k)DeviceDecision
K001482Aurenorm 75 KFEJT · Traditional 06/23/2000SE
K001481Palceram 49EJT · Traditional 06/23/2000SE
K001480Aurecast 40 BEJT · Traditional 06/21/2000SE
K001479Palceram 53EJT · Traditional 06/21/2000SE
K001477Aurelux Y 84 PremiumEJT · Traditional 06/20/2000SE

Questions and answers

When was Aurecast Super Inlay cleared by the FDA?

Aurecast Super Inlay (K001478) received a 510(k) decision of Substantially Equivalent on June 20, 2000, 40 days after the submission was received.

What is the product code of K001478?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.