AMALGAMATOR MODEL SDC--
Device Facts
| Record ID | K791410 |
|---|---|
| Device Name | AMALGAMATOR MODEL SDC-- |
| Applicant | Sierra Laboratories, Inc. |
| Product Code | EFD · Dental |
| Decision Date | Sep 19, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3100 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.
