← Product Code [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD) · K914341

# MIXOMAT AMALGAMATOR (K914341)

_Degussa AG · EFD · Nov 13, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K914341

## Device Facts

- **Applicant:** Degussa AG
- **Product Code:** [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD.md)
- **Decision Date:** Nov 13, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3100
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K914341](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K914341)

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