Closed Loop Auto Titration Device For Oral Appliances
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 patients 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.