IPT CAPSULE MIXER
Device Facts
| Record ID | K922203 |
|---|---|
| Device Name | IPT CAPSULE MIXER |
| Applicant | Ipt Technologies, Inc. |
| Product Code | EFD · Dental |
| Decision Date | Jun 3, 1992 |
| 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.