FDA approval for a dental device?

materious

I was wondering if anyone has any experience or knowledge about whether FDA approval is needed for a dental device, used by dentists, that goes into the mouth, but is not ingested and does not abrade tissue--something like a dental impression tray.  There is no medical claim to this device, it just assists dentists.Any suggestions would be great.  Thanks.

saravanan

If you make a diagnostic test that is CLIA waived (which means proven accurate and tested in a number of labs on a number of days by a number of people and dummy proof), then your test is FDA approved.