990 Gold
by Comprehensive Holistic Dentistry
510(k) K894924
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894924 | Date30 Oct 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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 990 Gold is a gold-based noble metal alloy, classified as a dental device. It is designed for dental restorations, including crowns, bridges, and fillings, providing a durable and biocompatible material for long-term oral use.
This device is supplied as a reusable alloy for dental professionals and has been cleared by the FDA under 510(k) number K894924. It is intended for use in clinical dental settings and adheres to regulatory standards outlined in 21 CFR 872.3060. The product code EJT categorizes it within dental materials, ensuring compliance with dental specialty requirements.
Questions
AI-generated answers, 19 Sep 2026
What types of dental restorations can the 990 Gold alloy be used for, and why is it considered suitable for these applications?
The 990 Gold alloy is specifically designed for dental restorations such as crowns, bridges, and fillings. It is considered suitable for these applications because it is a gold-based noble metal alloy, which provides exceptional durability and biocompatibility. This ensures long-term stability and reduces the risk of adverse reactions in the oral environment, making it ideal for clinical dental use.
Is the 990 Gold alloy reusable or single-use, and how should it be handled in a clinical setting?
The 990 Gold alloy is supplied as a reusable material for dental professionals. Since it is a metal alloy used in restorations, it is melted down, reshaped, and reused in multiple procedures. In a clinical setting, it should be handled with standard dental laboratory practices to maintain sterility and prevent contamination before use in patient restorations.
What regulatory pathway was followed for the FDA clearance of the 990 Gold alloy, and what does this mean for its use in dental practices?
The 990 Gold alloy was cleared by the FDA under a 510(k) submission (K894924) with a Traditional clearance type, determined to be Substantially Equivalent to a predicate device. This means the manufacturer demonstrated that it performs similarly to an existing, legally marketed dental alloy, ensuring compliance with 21 CFR 872.3060 for dental materials. Clinicians can rely on this clearance as evidence of its safety and effectiveness for dental restorations.
How is the 990 Gold alloy categorized in terms of regulatory classification, and what does this indicate about its risk level?
The 990 Gold alloy is classified as a Class II medical device under the FDA’s regulatory framework (as indicated by the device class in OpenFDA data). This classification means it carries a moderate risk and requires special controls to ensure its safety and performance, such as adherence to manufacturing standards and post-market surveillance. The product code EJT further confirms its classification within dental materials, reinforcing its intended use in clinical settings.