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) → PLH — Orthodontic Led Accessory

# PLH · Orthodontic Led Accessory

_Dental · 21 CFR 872.5470 · Class 2_

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

## Overview

- **Product Code:** PLH
- **Device Name:** Orthodontic Led 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230905](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/PLH/K230905.md) | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | Jun 9, 2023 | SESE |
| [K143120](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/PLH/K143120.md) | OrthoPulse | Biolux Research , Ltd. | Jul 24, 2015 | SESE |

## Top Applicants

- Biolux Research , Ltd. — 1 clearance
- Biolux Technology GmbH — 1 clearance

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

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