Global Implant Solutions, LLC
Country not established
- Devices
- 1
What Global Implant Solutions, LLC makes
Global Implant Solutions, LLC manufactures the OSSEOLINK Dental Implant System, a dental implant designed for osseointegration in oral and maxillofacial applications. The system is intended for use in procedures requiring stable fixation within the jawbone, including single-tooth and multi-tooth restorations.
The OSSEOLINK Dental Implant System is classified as a Class II medical device under FDA regulations and is subject to 510(k) clearance requirements. The company is based in the United States.
Catalogue
Osseolink Dental Implant System Ref K091878
Regimes: CE MDD 510(k) Registry: EUDAMED510(k)
Frequently asked questions
How many devices does Global Implant Solutions, LLC have in the registry?
The registry currently lists 1 device for Global Implant Solutions, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Implant Solutions, LLC's devices?
Among its 1 most recently registered device, Global Implant Solutions, LLC has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Global Implant Solutions, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Global Implant Solutions, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Global Implant Solutions, LLC in the registry?
The most recently registered devices listed for Global Implant Solutions, LLC include OSSEOLINK DENTAL IMPLANT SYSTEM.