Aurecast Super Inlay
by Aurex SA (Pty), Ltd. South Africa 510(k)
510(k) K001478 Product code EJT
Overview
The Aurecast Super Inlay is a dental device classified as an Alloy, Gold-Based Noble Metal, designed for use in the fabrication of cast restorations. It is composed primarily of noble metals, including gold, and is intended for dental applications such as inlays, where it provides structural support and aesthetic restoration to damaged or decayed teeth. This alloy is engineered to offer durability and biocompatibility for long-term use in dental prosthetics.
The device is supplied as a reusable dental alloy for casting inlays and is intended for use in clinical dental settings. It is not sterile at the time of supply but is intended to be processed according to standard dental laboratory protocols. The Aurecast Super Inlay is regulated under FDA 510(k) clearance (K001478) and falls under the classification of dental devices (product code EJT, regulation 872.3060). It is intended for use by trained dental professionals in the fabrication of restorations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001478 | Date20 Jun 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EJT
- FDA applicant
- Aurex SA (Pty) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Aurex SA (Pty), Ltd.
Questions
What is the Aurecast Super Inlay used for in dental restorations?
The Aurecast Super Inlay is a gold-based noble metal alloy designed specifically for fabricating cast restorations, such as inlays. It provides structural support and aesthetic restoration for damaged or decayed teeth, ensuring long-term durability and biocompatibility in dental prosthetics. This alloy is ideal for clinical settings where precise, high-quality restorations are required.
Is the Aurecast Super Inlay supplied sterile, and how should it be processed?
The Aurecast Super Inlay is not sterile at the time of supply. It must be processed according to standard dental laboratory protocols before use. This ensures proper preparation for casting inlays, maintaining the alloy’s integrity and biocompatibility for patient safety.
Is the Aurecast Super Inlay intended for single-use or reusable applications?
The Aurecast Super Inlay is designed as a reusable dental alloy for casting multiple inlays in a clinical or laboratory setting. Its noble metal composition allows for repeated use while maintaining structural and aesthetic properties, provided it is processed correctly between applications.
What regulatory approvals apply to the Aurecast Super Inlay?
The Aurecast Super Inlay holds FDA 510(k) clearance under the classification of dental devices (product code EJT, regulation 872.3060). This clearance confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in dental restorative applications.
How should the Aurecast Super Inlay be stored before use?
While the device data does not specify exact storage conditions, gold-based noble metal alloys like the Aurecast Super Inlay should generally be stored in a clean, dry environment to prevent contamination or oxidation. Proper packaging and adherence to manufacturer guidelines will help maintain the alloy’s quality and performance for casting purposes.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K001478