FDA investigating illegal handheld dental x-ray devices

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Permalink Reply by Ricklin on February 20, 2012 at 7:19pm

It's about time!! I think most of us have looked at the literally thousands of dental Eq. items on E-Bay.

There are many dangerous products being sold to US dentists, on a daily basis. I have already heard about Chinese handpiece's coming apart inside a patients mouth. Virtually every piece of equipment, small and large is available from China, shipped right to your Dr.s door.

The E-bay stuff is always shipped from outside the USA to circumvent the law.

Here are a couple of important points to help other reps stem the flow of this garbage.

The CE mark. This mark is similar to UL / FDA etc. but for the European union. Many accept the CE mark as an indicator of product quality and regulatory compliance. The CE mark on the Chinese products is short for "China Export" it has no meaning, and is only meant to mislead.

FDA    Most of the E-bay junk also will say FDA compliant, or even have an FDA logo in the listing. Guess what guys, the seller is lying!    If there is no FDA 510K number, the product is not FDA cleared.

If you are an independent rep be very wary of selling products from offshore. It's really easy to check out, just ask for the 510K number. Type FDA and the 510K number in the Google search box. That will take you directly to a copy of the 510K for that product.

Products that require a 510K can not be legally sold in the USA. You can be fined for selling these products.

Virtually any product that goes in the patients mouth must be FDA cleared. Chairs, units, and lights, are FDA cleared products, x-rays of course, curing lights, scalers, virtually all operatory equipment requires FDA compliance.

I have been approached a couple of times now to sell non-FDA products.  I will be glad to sell them, as long as all the regulatory requirements are met. Heck the cell phone on my hip right now is 100% made in China. Most of the electronics and computers we use are made in China. But those products do meet all the regulatory requirements to be sold here.

If you want to come and play in my yard, there are rules and regulations. Play by the rules, and you are welcome to play here.

Rick

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Permalink Reply by Dental Sales Rep on February 20, 2012 at 8:26pm

Well put Rick!!  Appreciate the points about CE and 510K.  Support the manufacturers that play by the rules. 

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