So if these dental instruments enter the United States through regulations or other means, how do dentists and dental technicians ensure that they do not buy grey market products and injure patients - and place their businesses under responsibility? Then, the first step is to practice common sense at the time of purchase.
"Dentists should remember that if a transaction seems too good, it is likely," said Hearn. "The grey market dealers buy and sell much less than the wholesale costs set by authorized dealers. For dental companies trying to look at bargains, this difference is tempting, but don't misunderstand: The risks are much greater than rewards.
"The first thing you can do is check the obvious and observable features that may constitute counterfeit or gray market products," he continued. "This includes defamatory, irregular, uneven or other low-quality printing, outdated product names, blocked bar codes, "export only" or "not registered for sale in the European Union or the United States" if the package does not emit any red flag And it looks the same with the official company packaging, you can consider the pricing structure, if the price of the product is significantly lower than the standard pricing, the product may be gray market or counterfeit. Another warning is if you from any of the manufacturer's authorized distribution channels One party purchases the product.
Dental professionals who are concerned about avoiding grey market goods can also ensure that the sellers they purchase products are reliable and trustworthy, and that each component is an original product of a company seeking and obtaining official FDA approval. "The point of sale is the main driver: Patella explained that you got the IFU's invoice, the physical packaging and the material label, all of which are attached to the company's brand." Strawman laser etched all titanium abutments to It clearly shows that it is an OEM device; In addition to the IFU and invoices, each Stuman CARES CAD/CAM repair version comes with a material component label detailing the origin and material composition. This is the Straumann brand. “
Is this worth the risk?
If the lab finds that they even accidentally used products purchased in the gray market, they may completely endanger their business. Hearne explained: “Purchasing products from unauthorized sources means that the typical choice of remediation through manufacturers is no longer an option.” “Buyers can seek recourse through traditional legal channels, but solving problems can be very It is difficult and time consuming.”
Redford echoed this warning. He said: “One of the first places lawyers discovered was the purchase history of the product.” “A lab owner buying from an unauthorized distributor or considering purchasing such a product should ask if he is worth the risk.”
The dentist needs help to ensure that their products are also safe for the patient. "[Dentists] should ensure that their laboratories only purchase products from the manufacturer's authorized distribution channels, and they are always conducting background checks on the new dealers they are recruiting," said Hearne. "The laboratory should be transparent about the procurement process and should be able to provide enough information to prove that the dental equipment they are buying comes from a reputable supplier."
“Dentists should be willing to talk to the lab about the source of the products they use,” Radford agreed. "If the material is an alloy or a ceramic, they should ask the laboratory to provide IdentAlloy or IdentCeram certificates, which can only be obtained directly from the manufacturer and authorized dealer."
All in all, every expert agrees that risk - albeit small - is not worth it. After all, these are real patients because the materials, equipment and supplies may not be safe and they are in danger. “Labs and dentists need to judge the products they buy based on their reputation and price,” Thomas suggested. "If it is much lower than the market price, then some bells should disappear and the purchase decision is theirs - their risk is theirs."
Hearne said: "The bottom line is that gray market products put patients' safety at risk and depend on the entire industry - manufacturers, distributors and personal dentists and laboratories are doing their best to keep patients safe." "By cooperation, we can all help Protect the integrity of the industry we work hard to build.”
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