Gray and black market dental products: Are you at risk?

By Allison DiMatteo

Imagine you’re in the market for a new camera, but you’re not interested in paying top dollar. In an effort to save money, you decide to browse through one of countless stores offering “deep discount” pricing on name brand, top-of-the-line cameras. Chances are, those cameras made their way or, worse yet, are counterfeit or even “Black Market” products. In other words, they might not be the real deal, the warranties — if any — are questionable, and as a buyer, you’d better beware.

Unfortunately, Gray and Black Market products aren’t limited to high-priced consumer electronics. Dental materials — everything from the composites used to create minimally invasive composite bonding veneers, to the impression materials and every other dental product are being sold in unauthorized ways to unsuspecting dentists.

What are Gray Market and Black Market Dental Products?

Gray Market dental products are those sold legitimately by a manufacturer intended for export or sale elsewhere, or those that are counterfeit to look like the real deal, which make their way back to the United States and are ultimately sold to dentists through unauthorized channels.

Black Market dental products are either stolen or otherwise transported and distributed in ways that avoid regular taxes and fees, making their way to the end user through risky and unknown supply chains.

More often than not, both types of products are outdated and expired, repackaged and relabeled. Usually the cost for these dental products and materials is significantly less than manufacturers originally intended. However, the ultimate cost in terms of treatment longevity and patient safety could be high, according to dental material science experts.

Poor Product, Material and Treatment Performance

When Gray Market, Black Market or counterfeit dental materials are used, dentists cannot be sure how those materials will perform, or how long the restorations they’re placing will last. That’s because most Gray and Black Market products travel back and forth between multiple countries via long shipping and handling processes that subject them to harsh stress and strain that negatively impact their effectiveness.

This is particularly true for the adhesives used to secure dental restorations in place, and for the impression materials used to create molds of your teeth. Inaccurate and faulty impressions ultimately result in improper and poorly fitting restorations that could chip, fracture or result in tooth decay. However, other dental materials — such as sealants, ceramics and composites — and products sold on the Gray or Black Market also could perform poorly or below acceptable standards.

The Law Isn’t Black and White

Gray and Black Market products making their way back into the United States typically were intended for sale in other countries and may not be approved by the FDA for use. As such, their packaging is usually altered or changed to appear consistent with other “for sale in the U.S.” products. Therefore, there’s no way to guarantee that Gray or Black Market products meet FDA standards or are FDA approved.

Experts have pointed out that while Black Market products are illegal according to the laws of most countries, the sale and purchase of products on the Gray Market approved by the FDA typically are not illegal. Again, however, because these products usually have been tampered with, it’s hard to determine if they’re the real thing.

What Can You Do As a Dentist?

Protect yourself by purchasing your dental supplies from Patterson Dental. At Patterson Dental we guarantee 100% we do not sell gray market materials. We are not going down this road as many of our competitors are currently doing. This is a serious issue in dentistry and you are liable for what goes in that patients mouth and so are we when it comes to materials. We have a strict policy and we hold the manufactures we distribute for to high standards as well. The FDA has some guidelines in place and they are trying to regulate this as well, but when you have unethical companies willing to do whatever it takes to sell product then the dentist and the consumer are the ones to suffer the consequences. This issue is getting bigger as the companies with no integrity play this game. I cannot say this boldly or strongly enough, PATTERSON DENTAL IS THE INTEGRITY COMPANY who wants to be your practice partner.