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?

Post your comments on this story

Are Dentists Liable for Lead in Dental Products?

Dentists Must Do Their Due Diligence

With recent news that some dental prostheses may be contaminated with lead, a lot of dentists are wondering if they’re legally liable for the quality of their dental lab work.

Unfortunately, there’s no simple answer to that question. However, one thing is clear: if you, the dentist, haven’t done your due diligence in selecting a reputable dental lab, you could be held responsible for the quality of their products.

“The liability situation is the same as it has always been, each party, the dentist and the dental laboratory must do their due diligence to comply with existing laws and regulations,” said Bennett Napier of the National Association of Dental Labs (NADL). “The liability exposure is different in each case specific scenario depending on a number of factors.”

But what exactly does “due diligence” mean? Well, it definitely means that you’re not choosing a dental lab on the internet because they have the cheapest crowns available. It does mean that you’ve researched your lab. Ideally, you’ve talked to the owner, visited the premises, and heard good reviews from other customers. If not… well, just be prepared for the possible consequences.

We at The Wealthy Dentist have been investigating what dentists may be able to do to protect themselves.

1. Make your dental lab tell you where the work is coming from and what it’s made of. Remarkably, most dental labs are NOT required to pass this information on to the prescribing dentist.

Florida and South Carolina have recently passed legislation that would require such disclosure, and other states are likely to follow suit soon. The NADL is working on a universal form for dental laboratories. Ohio has a similar form; the state’s dental board recommends but does not currently mandate use of these forms.

Highlights from the Ohio State Dental Board Laboratory Prescription & Point of Origin Form

Type of Restoration: _______

Materials:
– Porcelain to High Noble
– Porcelain to Noble
– Porcelain to Base Metal (NP)
– Full Metal High Noble
– Full Metal Noble
– Full Metal Base (NP)

This case will be:
– Fabricated by technicians at our own dental laboratory.
– Sent to another laboratory in the U.S. to be fabricated (Lab Name & Location)
– Sent to an overseas/foreign laboratory to be fabricated (Lab Name & Location)

See the full Ohio dental lab form

2. Make sure you’re giving your dental lab a full prescription.

An alarming number of dentists don’t actually give their dental labs all the information a technician needs to formulate a dental prosthesis. When information is missing (for example, what specific metals should be used), the technician is left to make an educated guess.

A checklist form can help ensure that dentists are giving their labs all the necessary information.

The Ohio State Dental Board has also released prescription guidelines. This form outlines the minimal information that should be included in a dentist’s prescription.

  1. Form must include basic information on patient, dentist and dental lab, as well as type of prosthesis.
  2. Crowns and bridges: Shade prescription, shade mapping, and material prescription.
  3. Partial and complete dentures: Shade prescription. tooth material prescription, tooth mold (shape) prescription, design of partial denture framework.
  4. Orthodontics or occlusal splints: explicit definition of type of prosthesis and instructions.
  5. Any additional explicit instructions from the dentist.
  6. Point of origin information should be included.

See the full dental lab prescription guidelines

3. Check your lab’s credentials.

The NADL’s Napier offers the following advice to dentists: “Dentists as part of minimizing their liability risk exposure can look at working with dental laboratories that are Certified Dental Laboratories or DAMAS accredited dental laboratories where third party validation occurs to ensure the lab’s quality system includes material traceability of lot and batch numbers of materials used for a specific dental restoration.”

The National Board for Certification in Dental Laboratory Technology (NBC) has developed a form for use by Certified Dental Technicians (CDTs).

Dental Restoration Disclosure Form
This case was manufactured by:
CDT Name: ___________________
CDT Number: ___________________
at ___________________(Dental Laboratory),
in ___________________(City, State, Country)
using the following FDA registered materials in the final restoration:
____________________________
____________________________
[Place Identalloy/IdentCERAM Sticker Here]

See the complete CDT dental restoration form

4. Stay current. It’s quite possible your state is considering new legislation for dentists and dental labs. You might consider setting up a Google News Alert to keep you informed of the latest news; just use “dental lab” and your state as keywords.

Can you suggest any additional resources? We’d love to see what forms you’re using with your dental lab. Just send us an email at DrWeeklyNewsUpdate@TheWealthyDentist.com!

Contrary to US Law, Veterans May Be Getting Foreign Dental Work

It’s Hard to “Buy American” When US Labs Secretly Outsource

Remember WBNS, the Ohio TV station that originally broke the story of lead-tainted dental lab restorations? Well, their investigative team is back with another report about dental labs.

VA hospitals and clinics provide US veterans with medical and dental care. In using government funds, these hospitals and clinics are legally committed (or at least, they’re supposed to be) to “Buy American” when it comes to medical products.

What is the Buy American Act?

In 1933, the US passed the “Buy America Act.” This legislation declared that the US government should preferentially purchase American products over foreign-made goods.

The exceptions to the law are as follows:

  • Foreign-made product is substantially cheaper than its US equivalent.
  • Foreign-made product is substantially higher in quality.
  • Product is not available domestically.
  • The President has waived the Act within international free-trade agreements such as the US-Canada FTA.

Learn more about the Buy American Act

In Columbus, Ohio, veterans may go to the Chalmers P. Wylie Veterans Clinic for dental work. Though the clinic manufactures some of their own dental restorations, the majority are sent to a Florida dental laboratory.

Florida: that’s buying American, right? Well, WBNS reports that’s not necessarily so.

They spoke to two former employees of the Florida lab who claim that most of the work is actually manufactured in China. Moreover, the station reports hearing similar stories about other dental labs that work with VA clinics. One ex-employee of a Texas lab alleged that the lab intentionally misled dentists into believing that Chinese-made work was produced in the US.

The lead scandal has raised awareness of the fact that many American labs outsource work to other countries. Not only do dental patients not know they’re getting foreign-made dental work, but often the dentists themselves don’t even know where the product was manufactured.

This is particularly relevant to veterans’ health because of the Buy American Act. While there aren’t laws in place to protect the average American consumer from foreign-made work (or, indeed, even inform them of it), veterans are in a different category. The law demands that their work be made domestically.

Post your own comments or read the WBNS report

ADA Left Holding the Bag in Dental Lab Controversy

When Scandal Strikes, Some Bury Their Heads in the Sand

Dentists and dental labs have been in the spotlight recently due to the news of lead-tainted dental products like crowns and bridges. Right now, we don’t know if it’s a widespread problem, whose fault it might be, or whose job it is to resolve this whole mess.

Though the story broke a few months ago, there’s been precious little actual information released on the subject. So what’s going on behind the scenes? Let’s examine the paper trail… You have to read between the lines a little, but it’s frightening how no agency seems willing to take responsibility for this public health hazard.

The correspondence starts on March 6, when the American Dental Association (ADA) sent nearly identical letters to both the Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Does this circle of ineptitude remind you of anything?

Here’s what the ADA had to say to the CDC: (PDF)

“Staff members from the ADA… have been in contact with the CDC’s Oral Health Division. We are undertaking our own efforts to study the problem, including random, objective testing of prosthetics from both overseas and domestic labs and will be happy to share that information with the CDC. Of course, any such testing by the ADA is no substitute for the CDC and other government agencies performing their mandated functions to protect the health and safety of the public.

“Although we are not aware of any risk to health based on the small amount of information available, we and our patients are looking to CDC to affirm that this is true or, if it is not, take the appropriate steps to protect the public. Accordingly, we request that the CDC keep the ADA informed of its efforts to identify the extent of the potential contamination and the health effects of lead in dental prosthetics as well as any CDC plans for action.”

The ADA wrote the same thing to the FDA. (PDF)

“Staff members from the ADA divisions of Science and Government and Public Affairs already have been in contact with the FDA’s Center for Devices and Radiological Health Dental Devices Branch…. Of course, any testing by the ADA is no substitute for the FDA and other government agencies performing their mandated functions to protect the health and safety of the public.”

Let me translate: “”The ADA is doing our own research, but it’s really the FDA’s or CDC’s job to determine if this is a problem and what we should do next.”” The ADA’s point is legitimate; a professional organization should not be expected to provide the same public health services as the government.

On March 18, the ADA again wrote to virtually identical letters to both the FDA (PDF) and CDC (PDF).

“Media reports on ‘contaminated’ dental materials produced in foreign dental laboratories have become more frequent. The reports have an increasingly alarming tone and a sense of urgency since we first wrote to you on March 6. As a result, dentists are fielding more inquiries from concerned patients and there are disquieting reports of patients declining recommended treatment because of unsubstantiated fears.

“We are eager to understand the extent of any problems with dental materials, whether they are produced in foreign or domestic dental laboratories. In particular, we ask that you provide some context for claims of possible health impacts of lead in dental prosthesis in the amounts reported in the media. While recognizing that much remains to be learned about this issue, some general information from the CDC/FDA about the likelihood of harm would be of great interest to both dentists and patients and should come from the federal agency whose mission is to protect the public’s health.

“We also look to your agency to reassure patients that recommended dental treatment should not be ignored. The ADA is asking both the CDC and the FDA to consider providing a media update that will reassure the public that government agencies are taking appropriate steps to protect dental patients and that oral health care should not be postponed.”

Let’s translate that again: “Hey, guys, this goes beyond the scope of the ADA’s job… Can the government please offer some guidance?”

On April 14, the FDA responded to the ADA.

“The FDA is taking this report very seriously. FDA’s Center for Devices and Radiological Health (CDRH) is also working to obtain information on the presence of lead in dental prosthetics.

“At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence.”

Translation: “Sorry ADA, the FDA has nothing to say on the topic. Ask us again later.”

On April 17, the CDC replied to the ADA’s letters.

“Thank you for your correspondence regarding media reports about the lead content in a dental prosthesis made in a dental laboratory in China. The CDC became aware of this issue through conversations with staff at the ADA’s Divisions of Science and Government and Public Affairs and through media interest in this story.

“As you indicated, the FDA has regulatory authority over dental products, including dental prosthetic materials, and for the registration of foreign laboratories that import dental products into the United States. It is our understanding that the FDA is already acting on this information, At this time, CDC has had no formal request for any type of engagement from a state of local health authority.

“Although CDC has no specific information regarding the case to which you refer, we can provide you with some general information on lead exposure. Many consumer products contain lead in trace amounts, and federal regulations limit the amount of lead in consumer products… Certainly, CDC recommends against the unnecessary use of lead in consumer products, including dental crowns.

“The recent media reports of lead in dental porcelain/metal crowns suggest a level of approximately 200 parts per million. Such small amounts of lead as reported, however, are extremely unlikely to cause adverse health effects in adults because the dental products wear out slowly, so the lead would be released in tiny amounts over time. Even at an increased rate, it is highly unlikely that this amount would be a health risk to an adult.

“It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories. CDC would be happy to assist ADA in interpreting the health impact of the testing of dental porcelains/meals that is currently underway. CDC will also provide any support if requested from the FDA, as that agency conducts further testing of these products.”

Translation: “It’s the FDA’s job, not the CDC’s. Maybe it’s the ADA’s job, but definitely not the CDC’s. And the amount of lead in dental prostheses is probably safe.”

Are you as amazed by what you’re reading as me?!? Here are a few of the most bothersome points:

  • “It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories,” writes the CDC, suggesting that it is the ADA’s responsibility to monitor the safety of dental products. The ADA is a private, voluntary professional organization funded by dues from member dentists. Testing and regulation is the government’s job, not the ADA’s.

    The ADA points this out in their initial letter, saying that “testing by the ADA is no substitute for the FDA, CDC and other government agencies performing their mandated functions to protect the health and safety of the public.”

  • The CDC became aware of this issue through conversations with staff at the ADA and through media interest in this story,” wrote the CDC.

    Really?!? Why was the ADA the one to bring this issue to the CDC’s attention? Does the CDC only investigate health threats that receive media attention?

  • “At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence,” says the FDA.

    The FDA took over a month to respond to the ADA. The organization in charge of regulating dental materials (you know, making sure they’re safe and lead-free) hasn’t offered the public any guidance on this threat.

The CDC’s passing the buck to the FDA, and the FDA doesn’t appear to be doing much of anything. But dentists are worried, patients are panicking, and public is desperate to know more. As the public face of dentistry in the US, the ADA is now forced to stand in for do-nothing government agencies. Doctors, it’s time to put on your hip-high waders… it is going to get really deep before anyone in the government takes action or gives definitive guidance.

 

Want to catch up on our coverage of this story?

 

Gold Stolen from Dental Lab

With the High Price of Gold, Things Will Only Get Worse

Five people in Ohio have been found guilty of stealing gold from a dental lab. A casting technician at the lab stole $170,000 worth of gold over 16 years. The four other defendants helped redeem the stolen gold for cash.

The investigation started after employees of a coin exchange noticed that one man repeatedly came in with suspicious globs of the precious metal.

Read more

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