Gray and Black Market Dental Products: Are You at Risk?

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 to the retailers via the “Gray Market” 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 used to create moulds of your teeth for precision crowns and porcelain veneers — also 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More often than not, both types of products are outdated and expired, repackaged and relabeled.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.

Legitimate products that are sold to dentists through the proper channels are manufactured nearby to control the materials, prevent expiration and prevent exposure to extreme temperatures that could negatively affect performance when used in dental treatments.

How Gray and Black Dental Markets Happen

Many businesses these days are trying to compete in the “global marketplace.” Unfortunately, not all countries can afford to pay the same prices for products that we pay here in the United States. As a result, many companies have different prices for their products throughout the world, and sometimes there’s quite a big difference between what consumers in one country pay for a product and what that product is sold for in another country. It’s no different with dental products and materials.

Because dental product pricing fluctuates between countries, it becomes more profitable for distribution chains to find unauthorized ways to sell the products back in the United States. The price will be lower than what U.S. dentists usually pay, but more than what overseas dentists are paying, so those unauthorized sellers make a bigger profit.

The Law Isn’t Black and White

The dental products, equipment and materials sold and used in the United States are regulated by the Food and Drug Administration (FDA) to ensure they meet appropriate standards, as well as confirm their safety and efficacy. For this reason the FDA inspects dental manufacturing facilities to ensure compliance with federal guidelines. The FDA also must approve products, materials and equipment before they are marketed and sold in the United States. Those approved by the FDA carry specific serial numbers on their packaging.

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?

Sometime in 2011, the FDA is expected to announce stronger rules for material and product labeling that will affect anything considered a medical device, including dental products, materials and equipment. Such packaging will enable manufacturers and their authorized dealers to better track and identify discrepancies in the distribution chain.

Additionally, dental product manufacturers are working harder to label and package products intended for foreign countries as a completely different product or material brand. This will make it harder for unauthorized channels to reintroduce the product into the United States on the Gray Market.

That’s comforting to know. It’s also good to know that dentists are concerned with the oral health of their patients and strive to deliver the best possible care using scientifically proven materials. Reputable dentists purchase legitimate and tested products from well-known and respected manufacturers and product dealers and likely will be willing to answer your questions about the materials they use and the manufacturers from whom they’ve purchased them.

Therefore, do not be afraid to ask about the type and brand of dental products your dentist will be using for your treatment. Understanding what’s involved with your treatment will enable you to have confidence in your dentist and participate actively in the process.