JEL-5 Gold Based Alloys & Precious Metal Alloys

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

510(k) Number

K882126 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Rd-2104

  Class II

  FDA 510(k) K002222 Active Cleared 31 Aug 2000

• Palladium-Based Dental Alloys for Porcelain Appli.

  Class II

  FDA 510(k) K880348 Active Cleared 11 May 1988

• Benchmark I

  Class II

  FDA 510(k) K922448 Active Cleared 5 Aug 1992

• Legacy-Xt

  Class II

  FDA 510(k) K922451 Active Cleared 5 Aug 1992

• Jeltemp

  Class II

  FDA 510(k) K991564 Active Cleared 23 Jun 1999

• Eureka

  Class II

  FDA 510(k) K933623 Active Cleared 1 Feb 1994

See all devices from J.F. Jelenko & Co., Inc. →

• What are JEL-5 Gold Based Alloys used for in dental applications?

  JEL-5 Gold Based Alloys are formulated for porcelain-to-metal, crown and bridge, and veneers with composite applications. They are designed for use in clinical settings by dental professionals.

• How are JEL-5 Gold Based Alloys supplied and what is their regulatory status?

  The device is supplied as a dental alloy and is regulated under FDA 510(k) clearance with product code EJT. It is manufactured by J.F. Jelenko & Co., Inc. and has been cleared for dental applications.

• What makes JEL-5 Gold Based Alloys different from other dental alloys?

  JEL-5 Gold Based Alloys feature a microfine grain structure that ensures greater consistency from melt-to-melt, providing reliable performance for dental restorations and prosthetics.

• Are there different sizes or models of JEL-5 Gold Based Alloys available?

  The device data does not specify different sizes or models of JEL-5 Gold Based Alloys. The information provided indicates it is a dental alloy formulation suitable for various dental applications.