FDA product code QCJ: Closed Loop Auto Titration Device For Oral Appliances
QCJ is the FDA product code for closed loop auto titration device for oral appliances. It is a Class II device, regulated under 21 CFR 872.5571 and reviewed by the Dental panel. Devices under QCJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Closed Loop Auto Titration Device For Oral Appliances |
| Device class | Class II |
| Regulation | 21 CFR 872.5571 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
Recalls for QCJ devices
openFDA lists no recalls for product code QCJ.
Frequently asked questions
What is FDA product code QCJ?
QCJ is the FDA product code for closed loop auto titration device for oral appliances. It is a Class II device, regulated under 21 CFR 872.5571 and reviewed by the Dental panel.
What device class is QCJ?
Class II, regulation 21 CFR 872.5571. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QCJ
- Run a recall and safety report across every QCJ manufacturer
- Watch product code QCJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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