# Closed Loop Auto Titration Device For Oral Appliances
> **Product code: QCJ** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5571
## Classification
- **FDA Product Code:** QCJ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5571
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study.  The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QCJ)
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