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  • Made in China

    PUBLISHED: Sunday, August 26, 2007
    Made in China?





    By Christy Strawser
    Macomb Daily Staff Writer


    George Burke, co-owner of Precision Crown and Bridge in St. Clair Shores, shows one of the crowns hand made in his shop. Burke, and many others, are worried that more and more American dentists are saving money by getting crowns from China.
    Macomb Daily photo by David Dalton

    Some dentists and lab technicians are asking consumers to add a new product to the list of scary exports from China, and the latest warning goes beyond regular, off-the-shelf consumer goods.
    In fact, thousands of Americans may have unknowingly allowed someone to cement this product right into their mouths.
    Dental crowns are the issue and experts say U.S. laboratories, including some in Macomb County, are reaching out to China to get them cheaper and faster.
    The overseas dental market is largely unregulated, some said, with no enforcement of the materials from which the crowns can be made.
    "Some patients are allergic to nickel or they're allergic to silver, and nobody's checking to see what metal China is using," said George Burke, co-owner of Precision Crown and Bridge in St. Clair Shores. "We're hearing about dogs and cats dying from Chinese products, and now they're doing this ... Nobody seems to be concerned, but somebody is going to get sick and die."
    The National Association of Dental Laboratories estimates between 10 percent and 15 percent of U.S. dental restorations, mostly crowns, are produced overseas. It's big business, with 12,000 dental labs in the United States generating about $5 billion a year in sales, according to the NADL.
    Olson International in Clinton Township is one of the dental crown suppliers importing crowns from China, though staff there refused to discuss how much work they're sending out or why.
    "We do some work with them (in China), that's the way the world's going," said Ron of Olson International, who would not give his last name or comment further.
    Burke said the average U.S.-made dental crown costs $110; many made in China are closer to $90. Mark Frichtel, a Pittsburgh lab owner, said he gets even lower costs in China, about $59 per crown.
    Follow the money
    The savings is not worth it, said Bennett Napier, co-executive director of the NADL, who said some dental labs are importing products from Pakistan, Turkey, Thailand, China, the Philippines and India.
    "Unfortunately, some of the countries where dental crowns and other similar devices are being manufactured don't have the same material compliance requirements as in the U.S.," Napier said. "Materials such as beryllium, a metal alloy, are commonly used around the world."
    Beryllium in very small amounts is allowed in dental crowns made in the U.S., but the metal is toxic in larger doses, Napier said.
    "There is no way for any federal agency to 100 percent monitor the safety of dental materials (from overseas)," Napier said. "FDA, or another agency, could randomly test shipments coming in from foreign dental laboratories ... much like other products coming in, there would be multiple crowns in one shipment, so it's somewhat like a needle in a haystack."
    What can patients do to stay safe? Experts say patients in line for crowns have to be proactive and question their dentist about where they plan to have it made. To be absolutely certain of its provenance, they may want to call the lab the dentist uses and ask if their products are made in-house or bought overseas.
    State Rep. Jack Brandenberg, R-Harrison Township, is just beginning to look into the issue. "It is a concern frankly," he said. "What I suggest I could do is see if some legislation could be written that would require a dentist to notify a patient and give them the option of knowing where the product came from."
    Dental crowns differ from tainted pet food, contaminated toothpaste, toxic toys and eroding auto tires because their safety goes beyond their content. Proper fit is a big issue in the detailed world of dental crowns, Burke said.
    Involved process
    Making a crown is a 20-step process to replace a missing or broken tooth in a patient's mouth. It starts with an impression of a patient's mouth, moves to a wax mold fed into a machine, and ends with a baked, hand-sanded, porcelain-veneered tooth cap that was made to fit. Burke believes China's crowns are closer to one-size-fits-all, which leaves gaps for decay and infection.
    "If it doesn't fit exactly, the tooth will decay through the inside out. If a crown is not sealed at the margins, that will happen," Burke said. "The doctor just fills it in, but it's not the same thing. Someone's going to have an infection or an allergic reaction, and they're going to chase it back to China. I guarantee it."
    The possibility of infectious disease also enters into play when an industry is unregulated, said Napier, who questions whether crowns could transmit a virulent infection like SARS.
    Napier said the lifespan of SARS germs was thought to be about seven days. Many U.S. labs that import crowns from China use overnight shipping.
    "If a dental restoration was not disinfected properly before it was placed in a shipping container, or disinfected before it was placed in a patient's mouth -- you can imagine the possibilities," Napier wrote in an e-mail.
    Frichtel, co-owner of Jesse and Frichtel Dental Labs, in Pittsburgh, said that is nonsense, adding, "The chances of that happening are next to nothing -- and if it's going to be a situation like that it will be because a dentist here didn't disinfect something the right way."
    Frichtel has labs in Shenzhen, China. He turned to China for help because he needed at least 100 technicians to fill his 14,000-square-foot factory, and he couldn't find enough qualified staff in the United States.
    He said his partners in China work 10 hours a day, six days a week on campuses devoted to producing dental products. They go home only on holidays. The factories are certified for safety by the FDA, which inspects the materials they use, Frichtel added. "All they're doing is working, learning and talking about teeth ... I think the quality is better than 85 percent of those made here," Frichtel said

  • Afraid in Pittsburgh

    My veneers are being made by the company you mentioned. The lab IN CHINA doesn't seem to understand the dentist's instructions and they continue to be sent back and forth and I've been fooling around for months. My teeth are now becoming sensitive and they already drilled down to the dentin. I'm afraid that I'll end up with root canals or lose my teeth because that company and the dentist are saving money!! On top of that, the National Association of Dental Laboratories is asking the FDA to regulate these Chinese imports due to toxic materials being used in their manufacture.

    A Chinese manufacturer was quoted: "It?s too costly to make lead-free products," says alloy company owner Wang Qinjuan. "Chinese products have to be sold cheaply in foreign markets, or they are not competitive." (Fairclough, para. 25). How scary is that??? Another article noted that the glazes used on veneers are contaminated with lead as well. I don't know what to do at this point!

    Comment


    • Is FDA Really Controlling Foreign Dental Labs?

      Dental experts say the crowns can contain dangerous levels of lead
      Dentists who use cut-price and potentially deadly crowns and dentures from China are putting their patients at risk, it was claimed today.
      The products are often made in unregulated laboratories and can contain dangerous levels of lead, dental experts warned.
      In the U.S., four cases of lead poisoning have been linked to Chinese dental fixtures. A laboratory test revealed that some contained 210 times the acceptable amount of the toxic metal.
      Richard Daniels, the chief executive of the Dental Laboratories Association, said the number of potentially dangerous imports was rising.
      "At this point nobody knows what the health risks are," he said.
      "The fact is the majority of NHS work will be coming from China or India in the next five years. We need to be moving towards proper regulation of the industry.
      "It's not just a matter for the NHS either - many of the big corporate groups also have agreements with factories in China to make their fixtures."
      Fears over the toxic metal content of crowns, veneers, bridges and dentures were raised when a 73-year- old Ohio woman became sick after being given a new crown made in China.
      Subsequent tests on other Chinese crowns revealed that some had dangerous levels of lead, forcing the U.S. National Association of Dental Laboratories to issue a warning to patients.
      Dangerous crowns and dentures have yet to be reported in Britain. However, there has recently been a huge surge in the number of dental fixtures imported from China into the UK.
      These now make up five per cent of the market, compared with less than one per cent three years ago.
      There have been concerns about other products made in the country, which is widely regarded as an emerging economic powerhouse.
      Last year, toy manufacturer Mattel launched a massive product recall after some of its products made in China were found to have high levels of lead.
      David Smith, a board member of the Association, said: "The worst case scenario is we'll end up with a large number of people in the UK with mouths full of lead and they've got no idea that that's the case.
      "It's a ridiculous situation. Mattel could simply pull its toys off the shelves when they realised there was a problem. It's nowhere near as simple if the contaminated product is a dental fixture in someone's mouth.
      "In theory what happened in America should never happen here as there are regulatory bodies which should prevent these problems in the UK.
      "But the truth is, if the situation isn't addressed then it is only a matter of time before there is a similar case as in the States. We've watered down all the rules in such a way that you could drive a bus through them.
      "In the end, the whole system is profiteering. Any savings made by outsourcing the work to China are never passed on to the patient."
      British dentists can now take an impression of a patient's tooth, send it to a Chinese lab by express post and get a crown back within four days.
      Suppliers of imported fixtures ask for around £10 per crown, compared to the £100 fee charged by British labs. The cost of a crown on the NHS is around £193.
      Medical devices in this country are tightly regulated, but the supply of dental fixtures is harder to control.
      Although the materials used to make crowns, bridges and dentures must carry a CE safety mark, there is no way of checking whether the manufacturer has used the correct materials.
      Mr Daniel said: "A British laboratory gets routine, unannounced inspections, but outside the EU no one is checking to see what is going into these products."
      See also: www.soundentistry.com

      Comment

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