Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3350](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3350) → ELO — Cusp, Gold And Stainless Steel

# ELO · Cusp, Gold And Stainless Steel

_Dental · 21 CFR 872.3350 · Class 1_

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

## Overview

- **Product Code:** ELO
- **Device Name:** Cusp, Gold And Stainless Steel
- **Regulation:** [21 CFR 872.3350](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3350)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group or stainless steel intended to provide a permanent cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable 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 (0 of 0)

_No cleared devices on record._

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

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