DENTAL-QUECKSILBER (DENTAL MERCURY)
Device Facts
| Record ID | K902388 |
|---|---|
| Device Name | DENTAL-QUECKSILBER (DENTAL MERCURY) |
| Applicant | Degussa AG |
| Product Code | ELY · Dental |
| Decision Date | Jun 28, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.
