Dental Labs in China: How Much Do You Really Know?

Dentists: How Much Do You Really Know about Dental Labs?

When lead was found in dental crowns made in China, the National Association of Dental Laboratories – the public face of America’s dental labs – was thrust into the spotlight. They have launched a website, http://www.whatsinyourmouth.us, providing consumers with information on the current lead scare.Dentists and dental labs

The typical NADL lab has 10-25 employees, but of course American dental labs come in all shapes and sizes. Single-technician labs still exist, but more are closing every year. Larger labs are becoming more common, as are corporations that operate multiple labs.

Chinese dental labs manufacturing for export to the US are not basement operations. While a large American dental lab might employ a hundred technicians, one in China might have a thousand. Bennett Napier, co-executive director of the NADL, traveled to China to visit laboratories and speak with lab representatives.

Located in south China, Veden Dental Labs has 400 employees who manufacture 4,000 units a day for US and European customers. “It’s a campus environment because they’re working 24-hour shifts,” explained Napier, describing the lab’s golf course and employee housing. “It makes it easier to have employees right there and if there are peak times, the people are right there on site and they can walk 20 feet from housing and go to work.” (Take a look inside a Chinese lab.)

Not all Chinese labs have on-site employee housing. However, the three-shift workday is typical. Operating 24 hours a day, these labs are able to churn out large volumes of work in short periods of time. A crown, for example, takes about four days.

In fact, sending work to China for manufacturing can actually save time. Even including shipping, the turnaround time for Chinese work tends to be a week. Some American labs take 10 days or longer.

And at as little as $29 a unit, the price of a Chinese-fabricated crown is impossible to beat. Foreign dental labs are changing the economic reality of lab work. In 2007 alone, the number of dental implants imported to the US from China increased by 35%.

What will this mean for American dental labs? Well, things are only going to get more difficult for small mom-and-pop operations. Some theorize that US dental labs will become increasingly divided into two categories: mega-labs run with with brutal efficiency, and an upper echelon of boutique labs catering to higher-end dental practices.

Some American dental “labs” don’t actually have their own laboratories or do their own manufacturing. They would more properly be called brokers. They accept orders from dentists, then send the work to actual dental labs (sometimes domestically, sometimes internationally) for manufacturing.

All dental labs are required to label products along the lines of “Manufactured by X Dental Lab, Shanghai, China” or “Distributed by X Dental Laboratory, New York, NY, USA.” But keep in mind that a product distributed by an American company may still have been manufactured in another country.

Dentists are not required to pass this information on to their patients. This is in stark contrast to Canada, where patients must sign a consent form if their dental work is manufactured outside of the country.

Of course the FDA does have regulations for importing dental prostheses into the US, but enforcement is limited. Each and every single manufactured crown or bridge is supposed to be accompanied by a 510k form filed with the FDA. (See a sample 510k form.)

In the case of the dental industry, the FDA does not regulate the final products per se; rather, they regulate the materials. Even if a dental crown was manufactured in China, it was likely produced using materials made in the US or Europe.

Or at least, that’s what the Chinese dental labs say. But how can a dentist be absolutely certain the lab uses the materials they say they do? That’s why a trusted dental lab is one of a dentist’s most valuable resources. If a dentist has not done his or her due diligence in selecting a lab, that dentist could be held liable.

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The Sickening News about Tainted Dental Lab Work

Chinese Dental Labs Turn Lead into Gold…?

When a 73-year-old Ohio woman fell ill, the news made national headlines. It wasn’t old age, or pneumonia, or cancer, or anything else you might expect. She had gotten lead poisoning from her new dental bridge.

Though she’d visited an American dentist, the bridge itself had been fabricated by a Chinese lab. Let me assure you that this is major news. I expect this health scandal will rock the world of dentistry.

Lead: How Many Parts Per Million Is Okay?
210 Discovered in one Chinese-made crown
160 Discovered in Ohio woman’s dental bridge
600 US legal limit in paint, toys, etc.
90 International standard for items such as toys (now being considered by US Congress)
1 Amount the UK permits in dental work
0.5-3 FDA guidelines for leachable lead in ceramic dishware
0.1 FDA limit in candy and food
0.1 Amount naturally in a healthy person’s blood

The Ohio woman received this new dental bridge last year. However, the restoration site became inflamed, and chewing was unmanageably painful. The bridge was ultimately removed, and she’s had further surgeries since. She sent the bridge in question to a scientific testing laboratory, and its surface allegedly tested at 160 parts per million of lead. She has since retained a lawyer and is planning to sue her dentist. (Please note that she is planning to sue her dentist, not the dental lab!)

Chinese exports have received massive amounts of bad press after various health scandals. Do you remember the animals who died from eating tainted pet food? Then at least 21 Panamanians died after taking poison cough syrup. Danger made its way onto US shelves via toxic toothpaste. Most recently, children’s toys were pulled from the market after it was discovered that the paint contained high amounts of lead. All of these products were manufactured in China.

I know what many of you dentists are wondering: Is this for real? What evidence is there that Chinese labs are systematically producing lead-tainted dental restorations? Well, here’s the evidence that has so far come to light on this developing story:

  1. The Ohio woman’s partial bridge apparently tested at 160 parts per million of lead.
  2. Ohio TV station WBNS then conducted its own investigation, releasing the results on February 27. With the help of a local dentist, they ordered crowns from four different Chinese dental labs. One of the eight crowns tested positive for lead. The porcelain facing contained 210 parts per million.
  3. The ADA announced that it had begun its own investigation, and had recommended that the FDA and CDC do the same. (Read the ADA’s response and their talking points for dentists.)

Though most press focuses on work manufactured in China, it’s worth noting that products are imported from many other countries, including India and Mexico. Imported restorations are dramatically less expensive than work produced domestically; in some cases, a crown from China may cost as much as 90% less. Cost-saving measures have led to more and more international manufacturing.

In the US, about 15-20% of dental lab work is produced in China (primarily bridges and crowns); that’s 7 million foreign crowns each year. Many of these products are distributed by American labs. Three years ago, less that 1% of UK dental restorations were produced in China; that number is now up to 5%.

Theoretically, the FDA monitors all dental products, whether produced domestically or abroad. The FDA has the authority to inspect any dental lab, foreign or domestic, that makes products sold in the US. Dental labs with overseas operations must register with the FDA. But within the US, only three states (Texas, Kentucky and South Carolina) require dental labs to register with state health departments.

The National Association of Dental Labs (NADL) officially recommended that the FDA close some of these legal loopholes. Needless to say, the organization that represents 1400 US dental labs has grave concerns about the allegations of tainted dental products.

The lead appears to be in the porcelain surface of some restorations. But many foreign labs use porcelain and other materials made in the US or Europe. So where does the lead come from? Many suspect the lead is in the glaze used to stain and seal the porcelain.

Many pottery glazes contain lead. The lead itself is not particularly a problem until it comes into contact with acid. The acid is what allows the lead to leach out of the glaze. For pottery, this isn’t much of a problem. But since the human mouth is an acidic environment, lead might be transferred to the patient’s bloodstream.

Let’s be clear on this point: The FDA says there should not be detectable levels of lead in the surface material of a dental prosthetic device. Lead poisoning generally causes non-specific symptoms such as aches, abnormal bowels, or high blood pressure. As a result, proper diagnosis can take years.

Though labs are supposed to label outsourced work they provide to dentists, anecdotal evidence suggests that dentists do not in fact always know where their restorations were manufactured. Dentists: Do you know where your restorations are manufactured? Estimates suggest that 25% of US dentists are sending lab work to China – and what’s more, many of these dentists don’t even know it. You can’t just assume your dental lab does its own manufacturing. As a dentist, it’s your job to make sure you can stand behind the safety of any restorations you do.

Anyhow, folks, that’s just the tip of the iceberg! Check your inbox this Friday for a survey question on foreign dental labs. And you definitely won’t want to miss my next editorial. Do you know which of the major US dental labs import or manufacture foreign dental work? I do! And next week, I’ll start naming names.

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Dental Labs: Lead Content a Prescription for Disaster

Chinese Labs in Hot Water After Dental Crowns Found to Contain Lead

“Yeah doc, my lab uses nothing but the best materials.”

Indulge me for a moment in listening in on an imaginary conversation between a dentist and dental lab manager.

“I’ve heard some scary news about dental crowns made in China that are contaminated with lead. Since your dental lab is located in the US, I can just assume the crowns are made in the US, right?” asks the uncertain dentist.

“Yeah doc, I use nothing but the best materials!” the dental lab replies. “You’ve always trusted me to give you true art, I’m an artist, right?”

“Yeah, you’re a great artist,” agrees the dentist. “But are you sure your products are safe?”

“Just trust me,” insists the dental lab. “And trust me, I have that insurance thing you asked for, what did you say it was, an insurance binder? Oh, plus products liability insurance? And I’ll get that 510k FDA filing to you right away. You’ve got nothing to worry about, I’m the best.”

After a week without receiving documentation, the doctor follows up.

“No, I’m not sending you insurance thing,” scoffs the dental lab. “That would be an invasion of my privacy. Besides, you’re the doctor! You put the crown in, so you own it. Anyhow, I don’t have the time to document my processes and I’m not sure how to do a manufacturing map, but who needs it? What I do is ART!”

Trust me: If you go with Joe’s Super-Quality Basement Dental Lab, this is what you’ll get.

Which dental labs send work to foreign countries?

The answer? A lot more than you might think!

Fifteen to 20% of crowns in the US are manufactured elsewhere. I estimate 25% of American dentists may be using products made in Chinese dental labs – and many of them do not know it.

That’s why it’s no longer good enough to take your dental lab’s word for it. As a dentist, you should foster a strong relationship with your dental lab. Know the people, know the facilities, know the products – and know the right questions to ask. (As in, “Are all your products manufactured in the US? What safety precautions do you have in place?”)

The first thing you need to know is that many US dental labs outsource work to China and other countries. Even if you got a product through a US-based dental lab, you cannot just assume it was manufactured in the USA.

Secondly, large dental lab chains are particularly likely to send work to Chinese labs. Manufacturing costs can be as little as one-tenth as those at US labs, and big companies can save a tremendous amount of money via this lower-cost production. Some dental labs do their own manufacturing, while others are are simply brokers or aggregators who offer sales and distribution.

Name some names already!

DENTSPLY opened an FDA registered dental laboratory—Prident—in China in 2006. The dental laboratory materials used there are the same materials cleared by the FDA, supplied by DENTSPLY and sold to its US laboratory customers.

Dent-USA, despite what the name may suggest, is in fact the largest dental laboratory in China. Needless to say, its products are sold and marketed in the US. Their website stresses that they provide products that are FDA-approved. (In Germany, the company goes by German-Dent.)

Trident Dental Laboratories is one of the top dental labs in the US. Though the company is based in California, I have it on good authority that they also own a lab in China. This fact is not mentioned on their website.

Let me be clear: None of these labs are accused of any wrongdoing. In fact, only two dental crowns (actually, one was a bridge) have tested positive for lead. More testing is needed to determine the scope of this problem. But there are two things we can be sure of:

  1. Any lead in dental prostheses is too much lead.
  2. The vast majority of dental prostheses manufactured in China are perfectly safe.

Oh, and don’t let me forget the most important thing! When it comes to dental labs, due diligence is the dentist’s responsibility.

Whose responsibility is it to protect the public from tainted dental lab work?

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Lead in Chinese Products Even a Problem in Comics…

Lead Scandal Makes the Funny Pages

All sorts of products anufactured in China have recently been alleged to be contaminated. Reports have surfaced of lead being found in everything from dental crowns to children’s toys. Johnny Hart, creator of BC, has clearly taken notice…

See more BC comic strips

Dentists Speak Out on Foreign Dental Lab Work

Threat of Lead Contamination Highlights Importance of the Relationship Between Dentist and Dental Lab

Unless you’ve been living under a rock, you’ve heard that there’s early evidence that some dental lab work from China may contain lead. So The Wealthy Dentist conducted a survey on the topic. Read the full foreign dental lab survey results or Jim Du Molin’s most recent editorial.)

Dental Survey Results When we asked whose responsibility it should be to protect the public from tainted dental work, the most common answer was “dentists.” However, some feel the FDA should enforce regulations, while others think the dental labs should police themselves. Very few respondents suggested that patients who are concerned should be responsible for checking with their dentists.

We also asked respondents if the current fuss about possible lead contamination in dental crowns from China is the next big scandal or just a tempest in a teapot. One-third of dentists feels this will be the next big scandal, while the remaining two-thirds see it as nothing more than a tempest in a teapot.

Finally, we asked dentists if they know where their lab work comes from. Sixty percent are certain that all restorations are manufactured within the USA, and another 20% believe that to be the case. Only 10% acknowledge that they know they use products made overseas.

Here are just a few of the comments dentists had on the topic of alleged lead contamination…

  • “My local lab is placing ‘made in America’ on all of the return cases for the patients to see.” (California dentist)
  • “I expect that my US labs are not sending my work off shore and using the quality of material I specify, but how do I know for sure?” (Michigan dentist)
  • We don’t know if this is a crisis. The labs and FDA need to test a large number of prosthetics that are produced in USA with foreign materials and in foreign countries.” (Washington dentist)
  • The FDA should bear the responsibility, because the labs won’t and the dentists can’t.” (North Carolina dentist)
  • “The last thing we need is more regulation. Let the labs police themselves.” (Pennsylvania dentist)
  • “If dentists are communicating with their labs and specifying which type of metals to be used, they should be confident the lab is giving them that. If the lab is trying to cut costs by using metals that may contain hazardous materials and are not making dentists aware, the lab should be held responsible.” (Kentucky dentist)
  • “I say the FDA should be in charge, but a big part of me does not like the idea of federal regulation, which already does not work particularly well.” (North Carolina dentist)
  • I don’t use labs that outsource to foreign countries. Those that choose to do so owe it to their patients to inform them of the practice.” (Arizona dentist)

Post your own comments or read the complete tainted dental lab work survey results

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