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

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

## Market data
- **Cleared 510(k) submissions:** 33
- **Registered establishments:** 39
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PNN)
---
*AI Analytics · CC0 1.0*