Skip to content

Aurenorm 75 KF

by Aurex SA (Pty), Ltd. South Africa 510(k)

510(k) K001482 Product code EJT

Overview

The Aurenorm 75 KF is a gold-based noble metal alloy designed for dental applications. This device is classified as a dental material, specifically intended for use in restorative procedures where high durability and biocompatibility are required. Its composition aligns with gold-based alloys used in dental restorations, ensuring compatibility with oral tissues and long-term performance.

Supplied as a reusable dental alloy, the Aurenorm 75 KF is intended for use in dental laboratories and clinical settings for crafting crowns, bridges, or other fixed prosthetics. The device is regulated under FDA 510(k) clearance (K001482) as a Class II dental product, adhering to regulatory standards for gold-based noble metal alloys. Storage and handling follow standard dental material protocols to maintain sterility and integrity before use.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001482 Date23 Jun 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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 Aurenorm 75 KF used for in dental procedures?

    The Aurenorm 75 KF is a gold-based noble metal alloy specifically designed for dental restorative procedures. It is used in dental laboratories and clinical settings to create crowns, bridges, and other fixed prosthetics. Its composition ensures high durability and biocompatibility, making it suitable for long-term use within oral tissues.

  • Is the Aurenorm 75 KF reusable or single-use?

    The Aurenorm 75 KF is supplied as a reusable dental alloy. It is intended for repeated use in crafting dental restorations, provided it is handled and stored according to standard dental material protocols to maintain its integrity and sterility before each use.

  • How should the Aurenorm 75 KF be stored to maintain its quality?

    The Aurenorm 75 KF should be stored following standard dental material protocols to preserve sterility and integrity. This typically involves keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and using appropriate packaging to prevent contamination or damage before use.

  • What regulatory approval does the Aurenorm 75 KF have?

    The Aurenorm 75 KF is regulated under FDA 510(k) clearance with the clearance number K001482. It is classified as a Class II dental product and is substantially equivalent to predicate devices, adhering to regulatory standards for gold-based noble metal alloys.

  • Can the Aurenorm 75 KF be used in all types of dental restorations?

    The Aurenorm 75 KF is intended for use in restorative procedures where high durability and biocompatibility are required, such as crowns, bridges, and fixed prosthetics. While it is versatile for these applications, its suitability for specific cases should be determined by dental professionals based on patient needs and clinical judgment.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K001482 24 fields · synced 22 Oct 2026