QCJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Closed Loop Auto Titration Device For Oral Appliances

Device class

Class II (moderate risk)

Regulation

21 CFR 872.5571

Medical specialty

Dental

FDA 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.

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