← Product Code [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD) · K791410

# AMALGAMATOR MODEL SDC-- (K791410)

_Sierra Laboratories, Inc. · EFD · Sep 19, 1979 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K791410

## Device Facts

- **Applicant:** Sierra Laboratories, Inc.
- **Product Code:** [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD.md)
- **Decision Date:** Sep 19, 1979
- **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/K791410](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K791410)

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