← Product Code [DZB](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB) · K932761

# SOFT-WEAR HEADGEAR AND SAFETY MODULES (K932761)

_Professional Positioners, Inc. · DZB · Oct 7, 1993 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K932761

## Device Facts

- **Applicant:** Professional Positioners, Inc.
- **Product Code:** [DZB](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB.md)
- **Decision Date:** Oct 7, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5500
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K932761](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K932761)

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