Oralsafe, Inc.
Country not established
- Devices
- 1
What Oralsafe, Inc. makes
Oralsafe, Inc. manufactures the ORALSAFE device, a medical product designed for oral hygiene and infection control in healthcare settings, particularly for patients with compromised oral health or those requiring ventilator support.
The ORALSAFE device is classified as Class I under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Oralsafe Ref K923469
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oralsafe, Inc. have in the registry?
The registry currently lists 1 device for Oralsafe, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oralsafe, Inc.'s devices?
Among its 1 most recently registered device, Oralsafe, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Oralsafe, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oralsafe, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Oralsafe, Inc. in the registry?
The most recently registered devices listed for Oralsafe, Inc. include ORALSAFE.