Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) → OYH — Orthodontic Vibratory Accessory

# OYH · Orthodontic Vibratory Accessory

_Dental · 21 CFR 872.5470 · Class 2_

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

## Overview

- **Product Code:** OYH
- **Device Name:** Orthodontic Vibratory Accessory
- **Regulation:** [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K183018](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OYH/K183018.md) | VPro5 | Propel Orthodontics, LLC | Nov 1, 2019 | SESE |
| [K170093](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OYH/K170093.md) | AcceleDent Optima | Orthoaccel Technology, Inc. | May 26, 2017 | SESE |
| [K153048](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OYH/K153048.md) | AcceleDent Aura | Orthoaccel Technologies, Inc. | Jul 8, 2016 | SESE |
| [K130643](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OYH/K130643.md) | ACCELEDENT AURA | Orthoaccel Technologies, Inc. | Apr 23, 2013 | SESE |
| [K110661](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OYH/K110661.md) | ACCELEDENT | Orthoaccel Technologies, Inc. | Nov 17, 2011 | SESE |

## Top Applicants

- Orthoaccel Technologies, Inc. — 3 clearances
- Orthoaccel Technology, Inc. — 1 clearance
- Propel Orthodontics, LLC — 1 clearance

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

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