Bioden Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 2
What Bioden Co., Ltd. makes
Bioden Co., Ltd. manufactures zirconia-based dental materials, including the Zircos-Com composite and non-sterile zirconia blocks, used for dental restorations and prosthetics.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Zircos-Com Ref K190139
Regimes: 510(k) Registry: 510(k)Non-Sterile Zirconia Block Ref K201492
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioden Co., Ltd. have in the registry?
The registry currently lists 2 devices for Bioden Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioden Co., Ltd.'s devices?
Among its 2 most recently registered devices, Bioden Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bioden Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bioden Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioden Co., Ltd. in the registry?
The most recently registered devices listed for Bioden Co., Ltd. include Zircos-Com and Non-Sterile Zirconia Block.