Is the appliance you’re using FDA cleared for OSA, or snoring only?

Did you know: Oral appliances can be FDA cleared for treatment of Obstructive Sleep Apnea (OSA) AND snoring, or snoring only!

It is important that you know this for the appliance(s) you are using for your patients, and sometimes medical insurance companies will even ask you to provide clearance numbers for the device you are using when filing pre-auths and claims!

So how do you find out?

A quick search on the FDA website!

The FDA provides a searchable 510k clearance database for medical devices (i.e. oral appliances for OSA). Here is the direct link to the search engine:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

You have several options to search the device you are looking for such as 510k number, decision date, model, applicant name, etc. Probably the easiest way to search is using the “Device Name” field.

For example – type in “SomnoDent” into the device name field and click the “search” button in lower right hand corner. This search will yield two different results for you: “Somnodent Herbst, Classic, Flex”, and “SomnoDent G2”.

The search will immediately display the Device name, Applicant, 510k number, and Decision date.
For additional information (like if the device is cleared for OSA & Snoring or Snoring only), click the name of the device.
You will see a summary of the registration information. To see if the device is registered for OSA and/or snoring, click on the “Device Classification Name” (for this example, the hyperlink reads “Device, Anti-snoring”)
You will see in the “Regulation Description” what the intended use is (for this example the description reads: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.”).