Xplora 3D Europe S.L
SpainFDA 510(k) applicant, unverified
- Devices
- 1
What Xplora 3D Europe S.L makes
Xplora 3D Europe S.L manufactures the Fas Aligner System, a device designed for orthodontic alignment and correction of dental irregularities.
The Fas Aligner System is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the US.
Catalogue
Fas Aligner System Ref K242929
510(k) 510(k)
Frequently asked questions
How many devices does Xplora 3D Europe S.L have in the registry?
The registry currently lists 1 device for Xplora 3D Europe S.L. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xplora 3D Europe S.L's devices?
Among its 1 most recently registered device, Xplora 3D Europe S.L has devices listed in FDA 510(k) (1 device).
What risk classes do Xplora 3D Europe S.L's devices fall under?
Among its 1 most recently registered device, the classes recorded for Xplora 3D Europe S.L's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xplora 3D Europe S.L in the registry?
The most recently registered devices listed for Xplora 3D Europe S.L include Fas Aligner System.