Roeko USA, Inc.
Country not established
- Devices
- 1
What Roeko USA, Inc. makes
Roeko USA, Inc. manufactures calcium hydroxide points, a dental material used for pulp capping and vital pulp therapy to promote healing and protect exposed dental pulp.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Roeko Calcium Hydroxide Points Ref K973539
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roeko USA, Inc. have in the registry?
The registry currently lists 1 device for Roeko USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roeko USA, Inc.'s devices?
Among its 1 most recently registered device, Roeko USA, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Roeko USA, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Roeko USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roeko USA, Inc. in the registry?
The most recently registered devices listed for Roeko USA, Inc. include ROEKO CALCIUM HYDROXIDE POINTS.