Dental

MATRx plus

Zephyr Sleep Technologies

FDA-cleared AI medical device

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.

FDA Submission Metadata

Submission number
DEN170090
Decision date
August 2018
FDA panel
Dental
Product code
QCJ

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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