Ximex, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Ximex, Ltd. makes
Ximex, Ltd. manufactures the PLAKOF, a Class I medical device designed for dental applications, specifically for the preparation and shaping of tooth surfaces during restorative procedures.
The PLAKOF is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the U.S. regulatory database. The company is based in the United States.
Catalogue
Plakof Ref K890910
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ximex, Ltd. have in the registry?
The registry currently lists 1 device for Ximex, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ximex, Ltd.'s devices?
Among its 1 most recently registered device, Ximex, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ximex, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ximex, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ximex, Ltd. in the registry?
The most recently registered devices listed for Ximex, Ltd. include PLAKOF.