Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3330](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3330) → ELZ — Crown, Preformed

# ELZ · Crown, Preformed

_Dental · 21 CFR 872.3330 · Class 1_

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

## Overview

- **Product Code:** ELZ
- **Device Name:** Crown, Preformed
- **Regulation:** [21 CFR 872.3330](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3330)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K091362](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K091362.md) | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. | Jun 29, 2009 | SESE |
| [K932759](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K932759.md) | TEMPOARY POLYCARBONATE CROWNS | South American Dental Exporting Corp. | Jul 22, 1994 | SESE |
| [K931352](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K931352.md) | PEDO JACKETS OR PJ'S | George M. Wilson, Dds | Jul 21, 1993 | SESE |
| [K913152](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K913152.md) | WHITER BITER CROWN | George M. Wilson, Dds | Sep 30, 1991 | SESE |
| [K912686](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K912686.md) | WHITER BITER CROWN | George M. Wilson, Dds | Sep 16, 1991 | SESE |
| [K892893](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K892893.md) | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB | Jun 6, 1989 | SESE |
| [K883325](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K883325.md) | PERFORMED CROWN (STAINLESS STEEL) | Whitecap Dental Co. | Sep 16, 1988 | SESE |
| [K771128](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K771128.md) | NEKO CERAMIC CONVENIENCE CROWNS | Sterndent Corp. | Jul 15, 1977 | SESE |
| [K770684](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELZ/K770684.md) | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Parker Laboratories, Inc. | Apr 26, 1977 | SESE |

## Top Applicants

- George M. Wilson, Dds — 3 clearances
- Whitecap Dental Co. — 1 clearance
- Svenska Dental Instruments AB — 1 clearance
- Sterndent Corp. — 1 clearance
- South American Dental Exporting Corp. — 1 clearance

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

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