Orthoplant Dental Lab
AustraliaFDA applicant, unverified
- Devices
- 1
What Orthoplant Dental Lab makes
Orthoplant Dental Lab manufactures the AirwayEase MAS, a dental appliance designed to manage airway obstruction during sleep, primarily for use in pediatric patients.
The AirwayEase MAS is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Airwayease Mas Ref K090436
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthoplant Dental Lab have in the registry?
The registry currently lists 1 device for Orthoplant Dental Lab. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthoplant Dental Lab's devices?
Among its 1 most recently registered device, Orthoplant Dental Lab has devices listed in FDA 510(k) (1 device).
What risk classes do Orthoplant Dental Lab's devices fall under?
Among its 1 most recently registered device, the classes recorded for Orthoplant Dental Lab's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthoplant Dental Lab in the registry?
The most recently registered devices listed for Orthoplant Dental Lab include AIRWAYEASE MAS.