Healthy Sleep Dental Laboratory
Country not established
- Devices
- 1
What Healthy Sleep Dental Laboratory makes
Healthy Sleep Dental Laboratory manufactures oral appliance devices designed to treat obstructive sleep apnea by repositioning the jaw and tongue during sleep. These appliances are custom-fitted to patients and intended for use under medical supervision.
The company’s products fall under FDA Class II devices and are authorised via the 510(k) pathway. They are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Healthy Sleep Appliance Ref K123410
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthy Sleep Dental Laboratory have in the registry?
The registry currently lists 1 device for Healthy Sleep Dental Laboratory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthy Sleep Dental Laboratory's devices?
Among its 1 most recently registered device, Healthy Sleep Dental Laboratory has devices listed in FDA 510(k) (1 device).
What risk classes do Healthy Sleep Dental Laboratory's devices fall under?
Among its 1 most recently registered device, the classes recorded for Healthy Sleep Dental Laboratory's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthy Sleep Dental Laboratory in the registry?
The most recently registered devices listed for Healthy Sleep Dental Laboratory include HEALTHY SLEEP APPLIANCE.