Jewel Cast III

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

510(k) Number

K003037 ↗

FDA Product Code

EJH

Device Class

Class II

Regulation

21 CFR Part 872.3710

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• KB58-Kf

  Class II

  FDA 510(k) K922958 Active Cleared 26 Feb 1993

• Prop. Conquest C&B Vlc Glaze/Sealant

  Class II

  FDA 510(k) K953381 Active Cleared 27 Sep 1995

• Crown and Bridge Dental Restorative Composite Syst

  Class II

  FDA 510(k) K894644 Active Cleared 20 Oct 1989

• Orosphere Hcdp

  Class II

  FDA 510(k) K890681 Active Cleared 2 May 1989

• Conquest Crystal

  Class II

  FDA 510(k) K932154 Active Cleared 15 Sep 1993

• Bond-It Dual Cure Activator

  Class II

  FDA 510(k) K953859 Active Cleared 7 Sep 1995

See all devices from Jeneric/Pentron, Inc. →

• What is the Jewel Cast III used for in dental restorations?

  The Jewel Cast III is a reusable base metal alloy specifically designed for fabricating cast or porcelain-fused-to-metal crowns and bridges. Its durable composition provides structural integrity for long-lasting dental prosthetics, making it ideal for both laboratory and clinical use in dental restorative procedures.

• Is the Jewel Cast III supplied as single-use or reusable?

  The Jewel Cast III is supplied as a reusable dental material. It is intended for repeated use in dental laboratories and clinics, provided it is handled and processed according to the manufacturer’s guidelines to maintain performance and safety.

• What regulatory pathway does the Jewel Cast III follow?

  The Jewel Cast III is regulated under the FDA’s 510(k) clearance pathway, classified as a Class II device with the product code EJH. It was granted clearance (K003037) in 2000 and is considered substantially equivalent to its predicate device, adhering to traditional review standards.

• How should the Jewel Cast III be stored to ensure optimal performance?

  While the provided data does not specify storage conditions explicitly, reusable dental alloys like Jewel Cast III typically require protection from moisture, contamination, and extreme temperatures. Follow the manufacturer’s instructions for proper packaging, sealing, and storage to preserve sterility and integrity before use.

• What distinguishes the Jewel Cast III from other base metal alloys?

  The Jewel Cast III is distinguished by its FDA-cleared formulation and its suitability for both cast and porcelain-fused-to-metal restorations. Its durable alloy composition is optimized for dental applications, ensuring compatibility with casting techniques used in crown and bridge fabrication while maintaining reliability in clinical settings.