Canada's Zirconia Grey Market - will your insurance cover you?

It is my understanding that in 2011 the larger dental manufacturers in Canada are aiming focus on the industry, dental labs and now dentists regarding education and awareness regarding the use of dental products that are `not Health Canada Approved'. Specifically Zirconia.

If a dental lab in Canada is using a Zirconia product that is not Health Canada Approved with a Class 3 Medical Device Licence and the device fails causing harm, injury and or monetary loss, are you liable?
That is common sense right. If you are on the receiving end of a complaint, legal investigation and or lawsuit it could potetially destroy your business (fast)

Patients are more educated than ever, just look at the below blog and get a sense of social media and it's power to educate. It's just a blog! Not twitter or other major form of media
http://dental-crown4.blogspot.com/2010/05/how-do-i-get-my-dental-lab-records.html


LMT
The recent case against Lee Culp, CDT, served as an important reminder to dental lab owners that lab technicians can be sued. Yes, the case ultimately was dropped, but that doesn’t mean you can relax. Rather, it’s time to do some serious thinking about the type of liability insurance you need to have and then to make sure you have it.
In this Article
Cooper: Buying an insurance policy does not prevent accidents. An insurance contract is designed to provide financial assistance based on coverage in exchange for premiums. Insurance companies are great resources for helping you with accident prevention and should be used. However, it is up to the dental lab to promote and provide a safe work environment and a safe product to the market place.

See this popular dental lab forum when a dentist steps in to write about a dental lab
http://dentallabnetwork.com/forums/f31/emax-3g-same-serious-question-7055/

Canadian regulatory authorities define
The term medical devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada

FDA Approval is not Health Canada Approval.
The Medical Devices Bureau of Health Canada has recognized four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. [3]. A guidance document for device classification is published by Heath Canada [4].

As you can see saving $10 or even $3 on a coping that is not legal for use in Canada, as you can see, might not be the best route to take short or long term.

If your product is not on this list or our milling center can not provide you with a medical device number - it is not legal for use in Canada

http://webprod.hc-sc.gc.ca/mdll-limh/prepareSearch-preparerRecherche.do?type=active&lang=eng


The price of these low cost illegal zirconia copings are driving down the price of layered crowns to a new low in Canada. Why would you to use a product that will reduce your potential revenue long term? When you can get great legitimate dental products from som many companies like Weiland, Nobel Procera, 3M ESPE and so so many others!

Potentially gray-market or counterfeit dental supplies can be identified in several ways, according to Dr. Gordon Christensen (Journal of the American Dental Association, June 2010, Vol. 141:6, pp. 712-715).

Low price
Unknown distributor name
Suspicious packaging
Expiration date

To avoid the problems potentially related to purchasing gray-market or counterfeit products, Dr. Christensen recommends:

Using authorized distributors
Expect to pay a fair market price for products
Avoid deeply discounted prices