Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3580](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3580) → ELN — Teeth, Preformed Gold Denture

# ELN · Teeth, Preformed Gold Denture

_Dental · 21 CFR 872.3580 · Class 1_

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

## Overview

- **Product Code:** ELN
- **Device Name:** Teeth, Preformed Gold Denture
- **Regulation:** [21 CFR 872.3580](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3580)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K770872](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELN/K770872.md) | IMPRESSION MATERIAL, ALGINATE | Espe GmbH (Us) | Jun 1, 1977 | SESE |

## Top Applicants

- Espe GmbH (Us) — 1 clearance

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

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