← Product Code [ELN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN) · K770872

# IMPRESSION MATERIAL, ALGINATE (K770872)

_Espe GmbH (Us) · ELN · Jun 1, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN/K770872

## Device Facts

- **Applicant:** Espe GmbH (Us)
- **Product Code:** [ELN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN.md)
- **Decision Date:** Jun 1, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3580
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN/K770872](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN/K770872)

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