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It’s Not a Simple Black and White Issue: Gray Market Dental Products


A “gray area” is an area or topic that is not clearly defined. What IS clearly defined, however, is that gray market dental products are swooping the industry, and dentists and their patients need to avoid purchasing or using these potentially unsafe products. Patterson Dental is working diligently to educate dentists on how to identify gray market dental products and dedicates a website,, specifically to this educational campaign.

According to an article in ADA News, "gray market" is a generic term that primarily refers to products that are traded or sold outside of the manufacturer's authorized distribution channels. It's different than the black market, where products are illegally manufactured or illegally sold.  

Gray market dental products may or may not satisfy FDA-related requirements or other laws and regulations. Of particular concern, products available on the gray market are often indistinguishable from defective or illegal counterfeit black market products that travel through the same distribution channels.

“Given the potential for dentists to unknowingly purchase counterfeit or dangerous products, we believe that it is important to raise awareness of this issue,” said Paul Guggenheim, President of Patterson Dental, in a recent press release.  “Dentists cannot be confident that products purchased through the gray market are genuine, safe or that they have been handled appropriately. By purchasing deeply discounted gray market products, we believe that dentists are exposing themselves and their patients to unnecessary risks.”

So how do you identify a potential gray market product? 

According to Patterson, ordering from authorized distributors can help ensure that purchases are authorized, legitimate and warranted.  Major product manufacturers will have lists of authorized distributors readily available for review. If you have a question about the legitimacy of a discounting distributor, do not hesitate to contact the manufacturer directly.

In addition, Patterson recommends, watch for these red flags:

- Is this deal too good to be true? If the product is selling for significantly below the known market price, research its market price by reviewing major dental retailer’s online or printed catalogs.

- Is the packaging legitimate?  Thoroughly examine the printing on all packages. If the package is unclear, smeared, irregular, uneven or not of the same quality you have previously observed on packaging of products with the same brand name, it may be from the gray market. Other packaging issues may include old product names, passed expiration dates, lack of a bar code, omitted disclaimers or other mandated regulatory verbiage. Be sure the label on the product matches the product name on the directions for use.

- Where did this package originate? Often products destined for one country may get rerouted and sold in another. Since regulations differ by country, make sure you know you’re buying exactly what you think you’re buying.

Dental Product Shopper spoke with Tim Rogan, Vice President of Marketing and Merchandise at Patterson, and he shared his insight into the gray and black market dental industry. Read more.

Is your lab using safe materials for your patients' restorations? Click here to learn more.

Image provided by Patterson Dental.



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