Osseofuse, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Osseofuse, Inc. makes
Osseofuse, Inc. manufactures dental implant systems, including the Osseofuse Dental Implant System and the One Plus Implant System, designed for oral and maxillofacial applications.
These products are regulated as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Osseofuse Dental Implant System Ref K131748
Regimes: 510(k) Registry: 510(k)One Plus Implant System Ref K133050
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osseofuse, Inc. have in the registry?
The registry currently lists 2 devices for Osseofuse, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osseofuse, Inc.'s devices?
Among its 2 most recently registered devices, Osseofuse, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Osseofuse, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Osseofuse, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osseofuse, Inc. in the registry?
The most recently registered devices listed for Osseofuse, Inc. include OSSEOFUSE DENTAL IMPLANT SYSTEM and ONE PLUS IMPLANT SYSTEM.