Product Code: QCJ FDA class 2 21 CFR 872.5571

Closed Loop Auto Titration Device For Oral Appliances

Dental

The Closed Loop Auto Titration Device For Oral Appliances uses feedback control to record changes in a patient's respiratory status related to mandibular repositioning during an overnight study, with data analyzed by a healthcare provider to identify patients with mild to moderate obstructive sleep apnea who may benefit from oral appliance therapy and to recommend a target mandibular position. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCJ under regulation 872.5571 in the Dental specialty. It is not an implant and is not life-sustaining.

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Basic Information

Product Code: QCJ
Device Class: FDA class 2
Regulation Number: 872.5571
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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