Palladium-Based Dental Alloys for Porcelain Appli.
by J.F. Jelenko & Co., Inc. 510(k)
Active
510(k) K880348
Overview
This device is a palladium-based dental alloy classified as a noble metal alloy, designed for use in dental restorations. It is primarily composed of palladium and intended for the fabrication of cast or porcelain-fused-to-metal crowns and bridges, providing structural support and aesthetic integration with porcelain materials.
The alloys are supplied in various formulations and are used in dental laboratories to create custom crowns and bridges. They are intended for single-use in dental restorations and are regulated under FDA 510(k) clearance (K880348) as a Class II device under regulation number 872.3060. The alloys are not sterile at time of supply and must be handled in a controlled dental laboratory environment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880348 | Date11 May 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from J.F. Jelenko & Co., Inc.
Questions
What are these palladium-based dental alloys used for?
These palladium-based dental alloys are designed specifically for fabricating cast or porcelain-fused-to-metal dental crowns and bridges. They provide structural integrity while allowing aesthetic integration with porcelain materials, ensuring durability and a natural appearance in restorative dentistry.
Are these alloys supplied sterile?
No, these palladium-based dental alloys are not sterile at the time of supply. They must be handled in a controlled dental laboratory environment to maintain cleanliness and prevent contamination before use in restorations.
Are these alloys intended for single-use or reuse?
These alloys are intended for single-use in dental restorations. Once used to create a crown or bridge, they are not designed to be reused, as this could compromise the integrity and safety of the restoration.
What regulatory pathway does this device follow?
This device follows the FDA 510(k) clearance pathway and is classified as a Class II medical device under regulation number 872.3060. It was granted substantial equivalence (SESE) by the FDA’s Dental Advisory Committee (DE) in 1988 under clearance number K880348.
How are these alloys supplied to dental laboratories?
The alloys are supplied in various formulations to dental laboratories for custom fabrication of crowns and bridges. They come in non-sterile form, requiring proper handling and preparation in a controlled lab setting before use in patient restorations.