Factor, Ii, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 2023623
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Factor, Ii, Inc. makes
Factor, II, Inc. makes medical devices such as the Royale II, Factor II Prosthetic Silicone Elastomer, and Magna Abutment, which are types of prosthetic and dental devices.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.
Catalogue
Royale Ii Ref K831095
510(k) 510(k)Factor Ii Prosthetic Silicone Elastomer Ref K880329
510(k) 510(k)Magna Abutment Ref K984297
510(k) 510(k)
Company details
- FDA FEI number
- 2023623
- Address
- 5642 White Mountain Ave, LAKESIDE, AZ, 85929
Frequently asked questions
How many devices does Factor, Ii, Inc. have in the registry?
The registry currently lists 3 devices for Factor, Ii, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Factor, Ii, Inc.'s devices?
Among its 3 most recently registered devices, Factor, Ii, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Factor, Ii, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Factor, Ii, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Factor, Ii, Inc. in the registry?
The most recently registered devices listed for Factor, Ii, Inc. include ROYALE II, FACTOR II PROSTHETIC SILICONE ELASTOMER and MAGNA ABUTMENT.