E.G. Bridge Gold
by J. Aderer, Inc. 510(k)
Active
510(k) K821613
Overview
The E.G. Bridge Gold is a dental device classified as an Alloy, Gold-Based Noble Metal, designed for fixed dental prosthodontics. This device consists of a gold-based alloy used to fabricate dental bridges, providing structural support and aesthetic integration for patients requiring multi-tooth replacement. Its composition adheres to dental alloy standards, ensuring biocompatibility and durability for long-term use in oral environments.
Supplied as a reusable dental casting alloy, the E.G. Bridge Gold is intended for use in dental laboratories and clinics for fabricating custom dental bridges. The device is regulated under FDA 510(k) clearance (K821613) and falls under FDA Class II (872.3060) for dental alloys. It is not single-use and requires proper handling, storage, and sterilization procedures as dictated by dental practice standards. The product code EJT identifies its submission category within the dental advisory committee (DE).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821613 | Date4 Jun 1982 | 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- Withdrawn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. Aderer, Inc.
Questions
What is the E.G. Bridge Gold used for in dental prosthodontics?
The E.G. Bridge Gold is a gold-based noble metal alloy designed specifically for fabricating fixed dental bridges. It provides both structural support and aesthetic integration for patients requiring multi-tooth replacement. Its composition adheres to dental alloy standards, ensuring long-term biocompatibility and durability within the oral environment.
Is the E.G. Bridge Gold a single-use or reusable device?
The E.G. Bridge Gold is a reusable dental casting alloy. It is intended for repeated use in dental laboratories and clinics to fabricate custom dental bridges, provided it is handled, stored, and sterilized according to standard dental practice protocols.
What regulatory approval does the E.G. Bridge Gold hold?
The E.G. Bridge Gold is regulated under FDA 510(k) clearance with the clearance number K821613. It falls under FDA Class II (product code 872.3060) for dental alloys and was determined to be substantially equivalent to a legally marketed predicate device. This classification ensures it meets established safety and performance standards for dental use.
How should the E.G. Bridge Gold be stored?
While the provided data does not specify exact storage instructions, dental alloys like the E.G. Bridge Gold should generally be stored in a clean, dry environment to prevent contamination or degradation. It is important to follow manufacturer guidelines and dental practice standards for proper handling, storage, and sterilization to maintain its integrity and performance.
What is the submission category for the E.G. Bridge Gold within the FDA?
The E.G. Bridge Gold is categorized under the product code EJT within the dental advisory committee (DE). This classification is used for administrative filing purposes and does not indicate a specific clinical use or indication but rather how the submission was categorized for review.