ACCU-MIX AMALGAMATOR
Device Facts
| Record ID | K910632 |
|---|---|
| Device Name | ACCU-MIX AMALGAMATOR |
| Applicant | Wykle Research, Inc. |
| Product Code | EFD · Dental |
| Decision Date | Mar 15, 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.
