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U.S. Department of Health and Human Services

Product Classification

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Device closed loop auto titration device for oral appliances
Regulation Description Auto titration device for oral appliances.
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.
Physical State Temporary intraoral mouthpiece attached to recorders and sensors to monitor physiologic responses to airflow and oxygen desaturation during sleep.
Technical Method Device functions as a closed loop auto titration device.
Target Area Oral cavity.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQCJ
Premarket Review Dental Devices (DHT1B)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5571
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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