← Product Code [EJW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW) · K901257

# WIRONTOM CLASP WIRE (K901257)

_Ivoclar North America, Inc. · EJW · Apr 25, 1990 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K901257

## Device Facts

- **Applicant:** Ivoclar North America, Inc.
- **Product Code:** [EJW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW.md)
- **Decision Date:** Apr 25, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3285
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K901257](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJW/K901257)

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