Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3910](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3910) → ELK — Teeth, Artificial, Backing And Facing

# ELK · Teeth, Artificial, Backing And Facing

_Dental · 21 CFR 872.3910 · Class 1_

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

## Overview

- **Product Code:** ELK
- **Device Name:** Teeth, Artificial, Backing And Facing
- **Regulation:** [21 CFR 872.3910](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3910)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth-colored facing, which is made of porcelain or plastic.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K811665](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELK/K811665.md) | SR-ISOCETTE | J. Aderer, Inc. | Jul 15, 1981 | SESE |
| [K760909](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELK/K760909.md) | THERMOMETER JARS AND CAPS | Plastics/Packaging | Dec 30, 1976 | SESE |

## Top Applicants

- Plastics/Packaging — 1 clearance
- J. Aderer, Inc. — 1 clearance

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

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