← Product Code [DYW](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW) · K861965

# UNITEK CERAMIC BRACKET SYSTEM (K861965)

_Unitek Corp. · DYW · Jun 9, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K861965

## Device Facts

- **Applicant:** Unitek Corp.
- **Product Code:** [DYW](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW.md)
- **Decision Date:** Jun 9, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5470
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K861965](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYW/K861965)

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