Udent, Inc.
Country not established
- Devices
- 1
What Udent, Inc. makes
Udent, Inc. manufactures orthodontic appliances, including the BRACE EZE system, which is designed for dental alignment and braces support. The product is intended for use in orthodontic treatment to assist in the positioning of teeth and retention.
The company’s devices fall under Class I regulatory classification in the US, with the BRACE EZE system authorised through the FDA’s 510(k) pathway. Products are listed in the FDA’s regulatory database under this clearance process. Udent, Inc. is headquartered in the United States.
Catalogue
Brace Eze Ref K020009
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Udent, Inc. have in the registry?
The registry currently lists 1 device for Udent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Udent, Inc.'s devices?
Among its 1 most recently registered device, Udent, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Udent, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Udent, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Udent, Inc. in the registry?
The most recently registered devices listed for Udent, Inc. include BRACE EZE.