← Product Code [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD) · K891064

# ESPE CAPMIX (K891064)

_Espe GmbH (Us) · EFD · May 30, 1989 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K891064

## Device Facts

- **Applicant:** Espe GmbH (Us)
- **Product Code:** [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD.md)
- **Decision Date:** May 30, 1989
- **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/K891064](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K891064)

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