# Orthodontic Led Accessory
> **Product code: PLH** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5470
## Classification
- **FDA Product Code:** PLH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5470
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Intended for use during orthodontic treatment.  It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PLH)
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