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Closed Loop Auto Titration Device For Oral Appliances

Closed Loop Auto Titration Device For Oral Appliances is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Closed Loop Auto Titration Device For Oral Appliances
Dental Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QCJ

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Class 2

21 CFR 872.5571

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Dental

Device Characteristics

No

No

No

Not Eligible

Definition

A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patientย’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.