GK Dental Amalgam Alloy
510(k) K923640
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923640 | Date12 Feb 1993 | 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- Withdrawn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
- EJJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3070
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The GK Dental Amalgam Alloy is a dental restorative material classified as an Alloy, Amalgam under FDA product code EJJ. It is a silver-based dental filling material designed for use in restoring decayed or damaged teeth, providing structural support and durability within the oral cavity. This material is intended for direct placement in prepared tooth cavities to restore function and aesthetics. Amalgam alloys are composed of a mixture of metals, primarily silver, tin, copper, and mercury, which harden upon setting to form a durable filling.
This dental amalgam alloy is supplied as a reusable material for dental professionals to mix and condense into prepared tooth cavities. It is regulated under 21 CFR 872.3070 and falls under Class II medical device classification, requiring a 510(k) clearance for market introduction. The product was granted Substantially Equivalent (SESE) status by the FDA in 1993 (K923640) and is intended for use in standard dental offices. No specific sterility or single-use designation is noted; it is prepared and applied by the practitioner at the time of procedure.
Questions
AI-generated answers, 1 Oct 2026
What is the GK Dental Amalgam Alloy used for?
The GK Dental Amalgam Alloy is designed specifically for restoring decayed or damaged teeth by providing structural support and durability within the oral cavity. It is placed directly into prepared tooth cavities to restore both function and aesthetics. The alloy hardens upon setting, forming a long-lasting filling material ideal for standard dental restorations.
How is the GK Dental Amalgam Alloy supplied and prepared?
The GK Dental Amalgam Alloy is supplied as a reusable material intended for dental professionals to mix and condense into prepared tooth cavities. Unlike pre-packaged or single-use materials, it requires on-site preparation by the practitioner at the time of the procedure. This ensures freshness and proper handling before application.
Is the GK Dental Amalgam Alloy sterile or single-use?
The GK Dental Amalgam Alloy is not designated as sterile or single-use. It is prepared and applied by the dental practitioner during the procedure, meaning sterility is maintained through proper handling and mixing techniques rather than pre-packaged sterility. Reusability is part of its design, allowing for repeated use in clinical settings.
What regulatory status does the GK Dental Amalgam Alloy hold?
The GK Dental Amalgam Alloy is classified under FDA product code EJJ as an Alloy, Amalgam, and is regulated under 21 CFR 872.3070. It was granted Substantially Equivalent (SESE) status by the FDA in 1993 (K923640) through a traditional 510(k) clearance process. This classification ensures it meets established safety and effectiveness standards for dental restorative materials.
Are there different sizes or models of the GK Dental Amalgam Alloy?
The provided data does not specify distinct sizes or models for the GK Dental Amalgam Alloy, but it is listed under multiple registration numbers (e.g., 3013557562, 3038718579) which may correspond to variations or lot-specific identifiers. These identifiers are typically used for tracking and regulatory purposes rather than indicating physical size differences. For precise sizing or model variations, consult the manufacturer’s technical documentation.