Palliag NF III
by Degussa Dental, Inc. 510(k)
Active
510(k) K883036
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883036 | Date12 Aug 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 19 Sep 2026
The Palliag NF III is a gold-based noble metal alloy used in dental restorations. This device falls under the classification of dental alloys, designed for applications requiring durable and biocompatible materials in fixed or removable dental prosthetics.
Supplied as a reusable dental material, the Palliag NF III is intended for use in dental laboratories and clinical settings. It is regulated under FDA 510(k) clearance (K883036) with a product code of EJT, adhering to dental industry standards. The device is not single-use and requires proper handling, storage, and sterilization protocols as dictated by dental practice guidelines.
Other devices from Degussa Dental, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of dental restorations can the Palliag NF III alloy be used for, and why is it considered durable?
The Palliag NF III is a gold-based noble metal alloy designed for fixed or removable dental prosthetics, such as crowns, bridges, or inlays. Its durability comes from the high-quality noble metal composition, which provides strength, resistance to corrosion, and long-term stability in the oral environment. This makes it suitable for applications requiring reliable, long-lasting restorations.
Is the Palliag NF III intended for single-use or can it be reused in dental procedures?
The Palliag NF III is explicitly labeled as a reusable dental material, meaning it is meant to be processed and used multiple times in dental laboratories or clinical settings. Proper handling, sterilization, and storage protocols must be followed to maintain its integrity and biocompatibility for repeated use.
How is the Palliag NF III regulated in the U.S., and what does the FDA 510(k) clearance indicate?
The Palliag NF III is regulated under the FDA’s 510(k) clearance process, with the clearance number K883036. This indicates that the manufacturer, Degussa Dental, Inc., has demonstrated that the device is *substantially equivalent* to a legally marketed predicate device (a previously approved gold-based noble metal alloy) in terms of safety and effectiveness. The product code EJT further categorizes it under dental alloys, confirming its classification.
What storage or sterilization guidelines should be followed for the Palliag NF III to ensure its usability?
Since the Palliag NF III is reusable, it must be stored and sterilized according to standard dental practice guidelines to prevent contamination and degradation. While specific protocols aren’t detailed in the data, typical practices for noble metal alloys—such as cleaning, autoclaving, or chemical sterilization—should be followed. Always refer to the manufacturer’s instructions or dental laboratory protocols for precise handling.
Does the Palliag NF III require any special handling due to its composition, and why is biocompatibility important?
Yes, as a gold-based noble metal alloy, the Palliag NF III must be handled with care to avoid scratches, oxidation, or contamination, which could compromise its biocompatibility or structural integrity. Biocompatibility is critical because the alloy comes into direct contact with oral tissues, and its noble metal composition minimizes allergic reactions or irritation, ensuring patient safety and long-term acceptance of the restoration.