← Product Code [ELZ](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ) · K770684

# CROWN, ACRYLIC, CORAL BRAND, PREFORMED (K770684)

_Parker Laboratories, Inc. · ELZ · Apr 26, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K770684

## Device Facts

- **Applicant:** Parker Laboratories, Inc.
- **Product Code:** [ELZ](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ.md)
- **Decision Date:** Apr 26, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3330
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K770684](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K770684)

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