ESPE CAPMIX
Device Facts
| Record ID | K891064 |
|---|---|
| Device Name | ESPE CAPMIX |
| Applicant | Espe GmbH (Us) |
| Product Code | EFD · Dental |
| Decision Date | May 30, 1989 |
| 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.
