FDA Accepted

The job of the Food and Drug Association (FDA) is to protect consumers and make sure that the benefits of a product outweigh the risks. The committee on medical devices determined at a meeting in the fall of 1997, that for purposes of treatment, snoring and OSA are considered medical diseases and that all oral appliances for treatment of these diseases fall under FDA requirements. By 2010 over 65 accepted devices had been granted premarket notification/510K acceptance, which means that they were found to be substantially equivalent to devices marketed before May 28, 1976; therefore, allowed to be marketed under the general controls of the Federal Food, Drug and Cosmetic Act rather than requiring specific FDA approval. Appliances which are new in concept (Class 3), with no prior similar device require Premarket Approval (PMA) by the FDA where submission of full statistical scientific data is required. The (FDA) assures:

  • Safety
  • Performance – does it do what it is suppose to do?
  • Effectiveness – is a significant target portion clinically successful?

All oral appliances are mandated to be available by prescription only, not over the counter. If you buy an oral device online or from a television ad, somewhere in the United States a medical professional is writing a prescription for you.

ALL DEVICES NOW ON THE MARKET ARE FDA ACCEPTED FOR THE TREATMENT OF OSA. 510K LIMITS ACCEPTANCE TO THE TREATMENT OF MILD OR MILD-MODERATE OSA ONLY AND TO THOSE OVER 18!

Published literature shows that custom fabricated devices are more effective and comfortable than prefabricated “boil and bite” devices.

A very good website supplying all kinds of information about FDA approved oral devices.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimpleSearch.cfm
When asked for the code, put in either LRK or LQZ.

While you will be shown some of the commercially available oral devices, you may be interested in pictures of more oral devices, not all of which are commercially available. Dr. Larry Barsh’s website, www.snoringisntsexy.com, provides you with not only all kinds of pictures but a good deal of information about sleep apnea. Remember, this is a sales site for dentists who buy space and limits dentists they refer to those who pay for referrals.

  

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