DeviceClearance

Product code QCJ— Dental

MATRx plus

Classification name
Closed Loop Auto Titration Device For Oral Appliances
Device class
Class 2
Regulation
21 CFR 872.5571
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QCJ under 21 CFR 872.5571, via openFDA

Market context for product code QCJ

FDA has cleared 1 device under product code QCJ, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QCJ

Recent clearances under product code QCJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.