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FDA approval for a dental device?

materiousmaterious Posts: 2subscriber
edited August 2009 in Developing Your Invention
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.
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