Microdental, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Microdental, Inc. makes
Microdental, Inc. manufactures obstructive sleep apnea (OSA) treatment devices, including the MicrO2 OSA Device with a Micro-Recorder and the MICR02 OSA Device. These products are designed for continuous positive airway pressure (CPAP) therapy, delivering pressurized air to maintain open airways during sleep.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The devices are listed in the FDA’s 510(k) database. Microdental, Inc. is based in the United States.
Catalogue
MicrO2 OSA Device with Micro-Recorder Ref K161624
Regimes: 510(k) Registry: 510(k)MICR02 Osa Device Ref K133683
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Microdental, Inc. have in the registry?
The registry currently lists 2 devices for Microdental, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Microdental, Inc.'s devices?
Among its 2 most recently registered devices, Microdental, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Microdental, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Microdental, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Microdental, Inc. in the registry?
The most recently registered devices listed for Microdental, Inc. include MicrO2 OSA Device with Micro-Recorder and MICR02 OSA DEVICE.