Smart Guard

Why is it that your website is devoted to the praises of smart guard as a night guard that works well for TMJ and yet in the informational pages inside the box it says that it is NOT FOR USE WITH TMJ? What kind of scam is this?

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Is SmartGuard is scam?
by: Dr. Spainhower

Hello Blogger,

I'll be happy to answer your questions of Why is my website about TMJ and I recommend the SmartGuard night guard when on the packaging it warns to Not use if you have TMJ...

It is very frustrating I know...it is to myself and SmartGuard Inc. as well.

See, the FDA approves or "Clears" medical devices like the SmartGuard for Two different categories. Number 1 RX (prescription) and #2 Over The Counter (OTC).

The SmartGuard was designed to treat TMJ disorders, and it IS Cleared to treat TMJ disorders when sold by a dentist. But the FDA required SmartGuard Inc. to put that warning on the OTC (Not RX) packaging to protect themselves and all involved as many other factors cause TMJ other than just night time clenching and grinding or a bad bite.

So, if you are trying to treat your TMJ disorders by yourself by purchasing OTC products and you don't get better or even get worse, then you wont' hold the FDA liable.

So, yes, it is unfortunate that that warning is on the packaging, but the SmartGuard night guards are indeed cleared by the FDA to treat TMJ disorders when purchased by a dentist.

Hope this helps explain the confusion.

Sincerely,
Dr. Spainhower

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