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Doctor's Orders

Getting the FDA to give your medical invention the thumbs up can be a challenge, so follow this prescription for approval.

This story appears in the November 2005 issue of Entrepreneur. Subscribe »

The entrepreneur: Dr. Jim Boyd, 46, a dentist in San Diego and founder of NTI-TSS Inc. in Misha-waka, Indiana, maker of the NTI

Product description: FDA-approved for migraine prevention, the NTI device is an inch-wide, custom-fitted night guard that snaps onto the two front teeth to prevent back teeth from clenching during sleep. The product sells to dentists for $20 per blank device; dentists typically purchase 10 blanks at a time, then customize the product for each patient. (Fitting and customization costs about $500, depending on the dentist.)

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