MIXOMAT AMALGAMATOR
Device Facts
| Record ID | K914341 |
|---|---|
| Device Name | MIXOMAT AMALGAMATOR |
| Applicant | Degussa AG |
| Product Code | EFD · Dental |
| Decision Date | Nov 13, 1991 |
| 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.
