Gold Core 35

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023501 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Sculpture Plus Nano-Hybrid Composite

  Class II

  FDA 510(k) K023742 Active Cleared 17 Jan 2003

• Sonata Micro Hybrid Composite

  Class II

  FDA 510(k) K020555 Active Cleared 22 Apr 2002

• Gold Core Plus

  Class II

  FDA 510(k) K023499 Active Cleared 13 Jan 2003

• Jewel Cast Plus

  Class II

  FDA 510(k) K023502 Active Cleared 18 Dec 2002

• What types of dental restorations can the Gold Core 35 alloy be used for?

  The Gold Core 35 is specifically designed for dental restorations including inlays, onlays, single crowns, bridges, and implant superstructures. It is also suitable as a substrate for low-fusing porcelains and composites, making it versatile for various clinical applications in restorative dentistry.

• Is the Gold Core 35 alloy reusable or single-use, and how is it supplied?

  The Gold Core 35 is supplied as a reusable dental alloy, intended for use in clinical dental settings. It is not a single-use product, meaning it can be melted down, reshaped, and reused multiple times for different restorations, provided it adheres to proper reprocessing protocols.

• What regulatory pathway did the Gold Core 35 follow to gain FDA clearance, and what does that mean for its use?

  The Gold Core 35 received FDA clearance under the Traditional 510(k) review pathway, classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for dental restorations.

• Is the Gold Core 35 sterile when supplied, or does it require sterilization before use?

  The provided data does not specify whether the Gold Core 35 is supplied in a sterile state. As a reusable dental alloy, it is typically not sterile out-of-the-box but must be cleaned, melted, and processed in a clinical setting according to standard dental protocols to ensure safety and sterility before use.

• What are the key applications of the Gold Core 35 alloy in dental implant restorations?

  The Gold Core 35 alloy is explicitly designed for use as an implant superstructure, meaning it can be fabricated to fit onto dental implants as a foundational framework. This makes it suitable for creating durable, long-lasting restorations for single or multiple implant-supported crowns or bridges.