Osstem Implant Company., Ltd. Chair Business
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000024564
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Osstem Implant Company., Ltd. Chair Business makes
Osstem Implant Company produces dental chair components, including the K5 Cart, K5 Mount, and K5 Swing—equipment designed for dental operatory setups to support chair functionality and mobility.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
K5 Cart, K5 Mount, K5 Swing Ref K251491
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDD Registry: EUDAMEDGUDID
- Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- KR-MF-000024564
- EUDAMED status
- Active
- EUDAMED registered name
- OSSTEM IMPLANT Co., Ltd. Chair Business
- EUDAMED abbreviated name
- OSSTEM IMPLANT Co., Ltd. Chair Business
- Registered address
- 192, Haebong-ro, Danwon-gu, 15428, Ansan-si, Gyeonggi-do, South Korea
- [email protected]
- PRRC contact
- Heekwon Son
Frequently asked questions
How many devices does Osstem Implant Company., Ltd. Chair Business have in the registry?
The registry currently lists 3 devices for Osstem Implant Company., Ltd. Chair Business. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osstem Implant Company., Ltd. Chair Business's devices?
Among its 3 most recently registered devices, Osstem Implant Company., Ltd. Chair Business has devices listed in EUDAMED (2 devices), FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Osstem Implant Company., Ltd. Chair Business's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Osstem Implant Company., Ltd. Chair Business's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from Osstem Implant Company., Ltd. Chair Business in the registry?
The most recently registered devices listed for Osstem Implant Company., Ltd. Chair Business include K5 Cart, K5 Mount, K5 Swing, K3 Mount and K3 Cart.