Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3285](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3285) → EJW — Clasp, Wire

# EJW · Clasp, Wire

_Dental · 21 CFR 872.3285 · Class 1_

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

## Overview

- **Product Code:** EJW
- **Device Name:** Clasp, Wire
- **Regulation:** [21 CFR 872.3285](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3285)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K901257](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K901257.md) | WIRONTOM CLASP WIRE | Ivoclar North America, Inc. | Apr 25, 1990 | SESE |
| [K881331](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K881331.md) | ORTHODONTIC NITINOL SPRINGS | Flexmedics | Apr 21, 1988 | SESE |
| [K872746](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K872746.md) | VITALLIUM WIRE | Austenal Dental, Inc. | Jul 21, 1987 | SESE |

## Top Applicants

- Austenal Dental, Inc. — 1 clearance
- Flexmedics — 1 clearance
- Ivoclar North America, Inc. — 1 clearance

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

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