Heads up. FDA Regulation changes - you could be exposed because of your dental laboratory website.
Reading through the last post from Bennet Napier and this caught my attention:
"Also, when you register you are required to provide your website address. FDA has been securing information from websites and apparently has been checking for 510(k)s pre-market approvals on certain devices that are branded by the dental laboratory. If you donât have a 510(k) on the product, then you shouldnât show that it treats any type of medical condition, symptom, disease or disorder such as sleep apnea. If you make a claim for treatment then you must either file a 510(k) on the device yourself or ensure that the manufacturer/specification developer has a 510(k). The fee to register a product through the 510(k) process is $4,960, or $2,480 for small businesses, which are defined as having $150 million or less in sales."