Avoiding the Gray: Minor Flaws Lead to Major Issues
By Matthew R. Petrosino, BA
In today’s economy, cost seems to be valued more than quality, making the dental marketplace ripe with opportunities for the sale of less-than-optimal products. Although there are many reputable dental supply dealers, there are those whose integrity is questionable.
The gray market has infiltrated all areas of the dental marketplace, even into the biggest and most trustworthy suppliers. Without scrutiny and vigilance, dentists may never be sure of the materials they purchase, or their origin. However, steps can be taken to save the embarrassment of failed restorations and possible legal action against the practice; manufacturers likely will not cover materials purchased from non-recommended dealers.1,2
A critical tool when purchasing materials, manufacturers typically provide a list on their websites of suggested dealers.1,2 These dealers are the most trusted by the manufacturer and have the proper licensing to sell their products.1,2 Distributors or companies that aren’t listed, but found through internet searches and other means, ultimately should be avoided. Additionally, it is not unreasonable to call the dealer to gain insight into product origin and gauge their trustworthiness.1,2
Overall, misbranded or adulterated products are strictly regulated under the Food and Drug Administration Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).3 Some of the most obvious differences between products sold in the United States and those sold elsewhere can be found in packaging.1-3 Because manufacturers often sell their products in countries outside the United States, dentists might believe the products are similar chemically. This is often true, but the way the products return to the United States is significant, since manufacturers often require specialized storage and handling instructions.1,2
Gray market items are often sold in foreign packaging or opened and repackaged.1,2 Although they may appear similar, subtle differences may include non-English labeling, differences in design (eg, color, text size/font, spelling), and labels that do not appear to match those on the manufacturer’s website.1,2
Also, these products are commonly marked with the "CE" symbol, which stands for "Conformité Européene" or "European Conformity."4,5 Manufacturers use this symbol to declare that the product complies with the requirements of relevant European health, safety, and environmental protection legislation.4,5 Although required for products sold in the European Union, the symbol is not specifically required in the United States.4,5
For example, on a suspected gray market dealer’s website, a product image for Prime & Bond® NT™ (DENTSPLY Caulk) demonstrated the "CE" symbol (in plain view) that was not seen on the packages available from the manufacturer’s recommended dealers. On the same dealer’s website, images of products from Kerr, 3M ESPE, and Kuraray Dental show major differences in the design and appearance of packaging, along with vastly lower prices than those found on the manufacturer-recommended dealer websites.
Although subtle, these nuances are important considerations, since counterfeiters and those who repackage gray market products often forgo finer details in order to save on cost.1,2 Careful scrutiny should always be exercised, even when viewing product images on a dealer’s website.
Personal Auction Websites
Online, user-driven auction sites allow users to sell just about anything at whatever cost they see fit. A useful tool for antiquing and sports memorable enthusiasts, it behooves dental professionals to be extremely cautious when ordering any product from these sites that will be used in the dental office.
For example, on one of the most commonly used auction websites, materials and tools made by Brasseler, Henry Schein, and Ivoclar Vivadent were found at a very low price, with some opened or missing original packaging. The seller who listed these products sold medical and dental supplies along with sports memorabilia and stamp collections.
Another online dental store on the same auction website offers consistently lower prices on dental materials and tools, including products from 3M ESPE and DENTSPLY, along with the manufacture and sale of the company’s own products that are CE Marked. Although the CE marking does show that the company is in conformity with the aforementioned European regulations, the marking applies to the products that they manufacture, not the brand name products they sell.4,5
Additionally, the company states that the manufacturing firm is "ISO Certified." A common misconception, International Organization of Standardization (ISO) Certification, specifically ISO 9001, does not apply to the products being manufactured.6 When a company states that they are going to produce "Product X" and do so while following generic management system standards that can be applied to any organization, they fall under the voluntary guidelines of ISO Certification.6 However, ISO does not regulate or legislate their standards, since it is a non-governmental organization and has no legal authority.6 Simply put, ISO Certification can be viewed as a way to standardize business forms and other tools to improve sales across international markets, not as a way to judge the integrity of a company or its products.6
Gray market dental products sold online may represent materials discontinued by the manufacturer.1,2 Recommended product dealers will not sell products that have been discontinued and instead will carry the replacement. However, questionable and/or unauthorized dealers have been found selling discontinued products, whether they are expired, near expiration, or inferior to the product that has since replaced it.1,2
It might be tempting to overlook these facts and purchase the product regardless based on its low price. Considering that many materials do not function properly after the manufacturer’s expiration date, this could pose an unnecessary risk.
Counterfeit dental materials, composed of the same raw materials used in legitimate products, demonstrate different handling capabilities and post-insertion behavior than expected —specifically with composites—and can lead to potentially harmful material and restoration failures.1,2 To avoid and/or identify counterfeit dental materials, dentists buying from dealers should look for the Material Safety Data Sheet (MSDS) for the product on the dealer’s website and/or with the product when it arrives.1,2 If one is not provided, be weary that the product received is not the actual product ordered.1,2 In general, the paper trail should be traceable back to the manufacturer.1,2 If not, the product may not be what it seems.1,2
Buying legitimate materials may increase cost initially but ultimately save the time and trouble associated with retreatment or potential legal action.1,2 Dental industry experts agree that the best way to ensure the safety and integrity of dental work is to buy products and materials from reputable, authorized dealers with a long track record with manufacturers. In addition, dentists should be sure that products purchased have DIN and lot numbers, proper packaging (including expiration dates and bar codes intact), and regulatory (eg, FDA) approval prior to use.1,2
1. Christensen GJ. Are you using "gray-market" or counterfeit dental products. J Am Dent Assoc. 2010;141(6):712-715.
2. Santerre P, Conn A, Teitelbaum B. Toronto academy of dentistry winter clinic panel discussion on grey market and counterfeit dental materials. J Can Dent Assoc. 2008;74(3):233-235.
3. Food and Drug Administration. 2000). Cosmetics—Guidance, Compliance & Regulatory Information. Retrieved January 2011, from https://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074248.htm.
4. International Trade Administration. 2009. CE Mark. Retrieved January 2011, from https://www.export.gov/cemark/index.asp.
5. The European Union (Europa). 2010. The European conformity marking. Retrieved January 2011, from https://ec.europa.eu/news/business/100419_en.htm.
6. International Organization for Standardization. 2010. About ISO. Retrieved January 2011, from www.iso.org/iso/about.