Opal Orthodontics by Ultradent Products
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- Devices
- 2
What Opal Orthodontics by Ultradent Products makes
Opal Orthodontics by Ultradent Products manufactures the Avex CX2, a Class II orthodontic adhesive designed for bonding brackets to teeth in fixed orthodontic treatment.
The Avex CX2 is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Avex CX2 And Avex CXI2 Ceramic Brackets Ref K113334
Regimes: 510(k) Registry: 510(k)Avex CX2 Ref K152779
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Opal Orthodontics by Ultradent Products have in the registry?
The registry currently lists 2 devices for Opal Orthodontics by Ultradent Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opal Orthodontics by Ultradent Products's devices?
Among its 2 most recently registered devices, Opal Orthodontics by Ultradent Products has devices listed in FDA 510(k) (2 devices).
What risk classes do Opal Orthodontics by Ultradent Products's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Opal Orthodontics by Ultradent Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Opal Orthodontics by Ultradent Products in the registry?
The most recently registered devices listed for Opal Orthodontics by Ultradent Products include AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS and Avex CX2.