# Sleep Appliances With Patient Monitoring
> **Product code: PLC** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5570
## Classification
- **FDA Product Code:** PLC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5570
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

For the treatment of night time snoring and mild to moderate  obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PLC)
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