The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular…
The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient’s pharyngeal space, improving their ability to exchange air and reducing their tendency to snore.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Narval CC | Listed by | Resmed PTY Ltd., Australia |
| FDA product code | LQZ |
| Device type | Device, Jaw Repositioning |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2018-10-18 |
| Record revised | 2026-03-31 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2019-09-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.