Oral Image, Inc.
Country not established
- Devices
- 1
What Oral Image, Inc. makes
Oral Image, Inc. manufactures QuickAligners, a type of dental aligner system designed for orthodontic treatment to gradually reposition teeth without traditional braces.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. QuickAligners are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
QuickAligners Ref K211537
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oral Image, Inc. have in the registry?
The registry currently lists 1 device for Oral Image, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oral Image, Inc.'s devices?
Among its 1 most recently registered device, Oral Image, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Oral Image, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oral Image, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oral Image, Inc. in the registry?
The most recently registered devices listed for Oral Image, Inc. include QuickAligners.