# Bracket, Ceramic, Orthodontic
> **Product code: NJM** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5470
## Classification
- **FDA Product Code:** NJM
- **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

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

## Market data
- **Cleared 510(k) submissions:** 60
- **Registered establishments:** 50
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NJM)
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