← Product Code [EJF](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/EJF) · K901024

# STAINLESS STEEL DENTAL WIRES AND CLASPS (K901024)

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

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/EJF/K901024

## Device Facts

- **Applicant:** Ivoclar North America, Inc.
- **Product Code:** [EJF](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/EJF.md)
- **Decision Date:** Apr 25, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5410
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/EJF/K901024](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/EJF/K901024)

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