Universal Orthodontic Laboratory, Inc.
Country not established
- Devices
- 1
What Universal Orthodontic Laboratory, Inc. makes
Universal Orthodontic Laboratory, Inc. manufactures removable orthodontic aligners, including the U-Aligner, designed for dental alignment and correction of malocclusions.
The company’s products are regulated as Class II devices under the FDA’s 510(k) clearance pathway and are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
U-Aligner Ref K191308
510(k) 510(k)
Frequently asked questions
How many devices does Universal Orthodontic Laboratory, Inc. have in the registry?
The registry currently lists 1 device for Universal Orthodontic Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Universal Orthodontic Laboratory, Inc.'s devices?
Among its 1 most recently registered device, Universal Orthodontic Laboratory, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Universal Orthodontic Laboratory, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Universal Orthodontic Laboratory, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Universal Orthodontic Laboratory, Inc. in the registry?
The most recently registered devices listed for Universal Orthodontic Laboratory, Inc. include U-Aligner.