Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3900](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3900) → ELJ — Teeth, Artificial, Posterior With Metal Insert

# ELJ · Teeth, Artificial, Posterior With Metal Insert

_Dental · 21 CFR 872.3900 · Class 1_

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

## Overview

- **Product Code:** ELJ
- **Device Name:** Teeth, Artificial, Posterior With Metal Insert
- **Regulation:** [21 CFR 872.3900](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3900)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A posterior artificial tooth with a metal insert is a porcelain device with an insert made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to replace a natural tooth. The device is attached to surrounding teeth by a bridge and is intended to provide both an improvement in appearance and functional occlusion (bite).

## 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._

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com