QCJ

Closed Loop Auto Titration Device For Oral Appliances

Product code

QCJ

Device name

Closed Loop Auto Titration Device For Oral Appliances

Device class

Class 2

21 CFR

21 CFR 872.5571

Medical specialty

Dental

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).