Counterfeit dental products and genuine products distributed through unofficial channels—the grey market—present a serious problem. Given that such products often bypass applicable quality and safety standards or are distributed without appropriate oversight, their sale and use in clinics and laboratories can have serious consequences. The responsibility—and the risk—lies with those providing treatment, and it is therefore imperative that they exercise due diligence when sourcing products and verifying their authenticity.

The risks of grey market dental products

Products from the grey market often have a distribution history that may be difficult to trace. They may have been diverted from authorised channels, repackaged, or stored and transported under unsuitable conditions. In many cases, they may no longer meet the manufacturer’s original specifications or may not comply with the regulatory requirements of the country in which they are sold.

The risks are real—and often not immediately visible. Products may be expired, damaged or incorrectly labelled. Improper storage or transport can lead to contamination, chemical degradation or altered material properties. The result can be compromised treatment outcomes or, in the worst case, harm to both patients and users. In addition, products sourced outside authorised distribution channels typically come with no warranty or customer support.

Counterfeit dental products lack quality control

Owing to an absence of regulatory oversight in the manufacturing process, the risks of counterfeit products are particularly acute. Markus Heinz, CEO of the Ivoclar Group, explained: “Counterfeit dental products are a serious concern for everyone in the dental community, as these products are not produced under the stringent quality control guidelines of a medical device manufacturer such as Ivoclar.”

Heinz added: “To prevent such risks and thereby protect patients and our customers, we exclusively work with business partners who meet strict compliance requirements and cooperate with official authorities to fight illicit market activity.” Ivoclar’s actions in this area have already helped local authorities in China discover and close factories manufacturing counterfeit products.

Warning signs for dental professionals

Dental professionals must be able to identify risks at an early stage to avoid serious repercussions. In practice, several warning signs may indicate counterfeit or grey market products, including:

• pricing that is significantly below market level;
• irregularities in packaging or labelling;
• sales through unauthorised dealers;
• unusual product availability; and
• lack of warranty or support services.

New verification capability for the highest safety standards

For Ivoclar, patient safety is paramount. To help dental professionals ensure that products bearing the Ivoclar name are genuine, the company provides information on its website about the signs and risks of illicit and grey market goods, as well as an overview of authorised distributors. In addition, the company has launched a new verification function, providing customers with a simple tool to quickly and reliably check product authenticity.

The verification function is already available for the Ivotion portfolio and the ProArt CAD Try-In discs. Their packaging carries a peel-off product seal bearing a QR code that can easily be scanned with a smartphone—no app is required. The user is then directed to an Ivoclar webpage and asked to enter the PIN located beneath the QR code. After entering the PIN, the customer can immediately see whether the product is genuine and meets the highest safety standards. If anything appears to be incorrect, Ivoclar’s customer care is available to assist. The initiative offers a simple, convenient and reliable way to ensure that users can check the quality and safety of the products they use every day.

Ivoclar plans to gradually expand the verification function to additional products in its portfolio. Moreover, it plans to link further features to the QR code, such as useful and relevant product information and instructions for use. Further information on the verification programme is available on Ivoclar’s website.

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