Pentax Corp.
Country not established
- Devices
- 1
What Pentax Corp. makes
Pentax Corp. manufactures bone graft substitutes, specifically the APACERAM product line, which are used to replace or augment bone tissue in surgical procedures.
The company’s portfolio is regulated under Class II medical devices in the United States, with devices authorised through the FDA’s 510(k) clearance process. Pentax Corp. is based in the US.
Catalogue
Apaceram Bone Graft Substitute Ref K071912
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pentax Corp. have in the registry?
The registry currently lists 1 device for Pentax Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pentax Corp.'s devices?
Among its 1 most recently registered device, Pentax Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Pentax Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pentax Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pentax Corp. in the registry?
The most recently registered devices listed for Pentax Corp. include APACERAM BONE GRAFT SUBSTITUTE.