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QCJ — Closed Loop Auto Titration Device For Oral Appliances Class II

FDA Device Classification

FDA product code QCJ covers "Closed Loop Auto Titration Device For Oral Appliances", a Class II medical device regulated under 21 CFR 872.5571. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QCJ
Device Class
Class II
Regulation Number
872.5571
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN170090zephyr sleep technologiesMATRx plusAugust 23, 2018

FDA data resources