← Product Code [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD) · K923974

# SILIMAT PLUS (K923974)

_Ivoclar North America, Inc. · EFD · Oct 6, 1992 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K923974

## Device Facts

- **Applicant:** Ivoclar North America, Inc.
- **Product Code:** [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD.md)
- **Decision Date:** Oct 6, 1992
- **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/K923974](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K923974)

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