People quickly assumed the problem was with foreign dental labs, particularly those in China.

The Wealthy Dentist conducted a survey asking dentists a number of questions about foreign dental labs.

One dentist said,  “Patients have been systematically kept in the dark when it comes to dental procedures.  Patients should be given informed consent when choosing materials.”

Another dentist complained, “Too many dentists are accommodating low insurance payment schedules by buying materials and fabrications that are too cheap.  It doesn’t seem to matter that it compromises the health of the patient.”

Click on Play to hear more of what dentists have to say about foreign dental labs –

What has been your experience with dental labs?

So we asked dentists who should be responsible for the safety of dental products. One third said the FDA, one quarter said dental labs should police themselves, and 41% said dentists should take responsibility.

“My local lab is placing 'made in America' on all of the return cases for the patients to see,” mentioned one dentist.

“Too many dentists are accommodating low dental insurance payment schedules by buying their dental materials and laboratory fabrications that are too cheap," complained another. "It doesn't seem to matter that it compromises the health of the patient."

Read more: Lead found in dental crown from China: Dentist Survey Results

But among dentists offering Cerec restorations, 61% think it's a useful dental marketing tool. And only 15% of Cerec dentists report they are disappointed with it.

Don't know what CEREC is? The name stands for Chairside Economical Restoration of Esthetic Ceramics. Cerec dentists use computer-assisted technology to fabricate a customized porcelain restoration, often a dental crown. You can get a Cerec restoration in a single appointment, while traditional porcelain crowns are fabricated by dental labs and require two appointments.
Learn more here: http://en.wikipedia.org/wiki/CEREC

Here's what dentists have to say about CEREC:

• “The idea is great, but the restorations are not close to the quality of lab-fabricated restorations.” (Tennessee dentist)
• "It has been the best investment I have made in my practice." (General dentist)
• “It only means something to the average patient if you call it ‘same day crown.’” (Minnesota dentist)
• “Cerec is the greatest invention in the history of dentistry. Those who don't like it are either not willing to take the time to learn it or haven't bought it and need an excuse as to why.” (Illinois dentist)
• “I am glad I got the Cerec, but there were times along the way I would have gladly given it back if I could have got a full refund. It definitely is where the future is going, so we need to master this technology.” (California dentist)
• "I've replaced many fractured Cerec restorations that come into my practice." (General dentist)
• “The best economic investment we ever made in our practice. It has allowed our practice to experience an 8% growth in 2009 while the majority of the practices in our state experienced a 30 to 40% decline.” (Michigan dentist)
• “Puts you in the special list of dentists that are on top of the newest, the best and ahead of the crowd.” (Pennsylvania prosthodontist)
• “Powder all the teeth and then the patient swallows and all the powder is gone and then you re-powder and they swallow and all the powder is gone…repeat ad infinitum until you get tired of it and throw your ($100,000) machine away.” (California dentist)
• "The smartest thing I have EVER done in my career is to purchase (and master) a CEREC machine. The restorations are more precise, beautiful, and predictable than any lab… I get tons of referrals because I have one; it just continually blows my mind that more dentists have not clued into this. NO WAY would I practice without it." (General dentist)
• "We've had Cerec for 1 1/2 years are are now pretty satisfied. But the learning curve was LONG and I'm still learning.” (New Mexico dentist)
• "Initially I was disappointed with CEREC due to a steep learning curve, technical shortcomings and disruption to our normal scheduling routine. But now I must admit that with experience and the latest camera and software upgrades I love it, and I'm getting restorations that are often better than my lab. Patients really appreciate single visit dentistry and they are fascinated by the technology. It has reduced my lab bills significantly which more than offsets the cost of the machine." (General dentist)
• "I do not think Cerec has the name recognition of Invisalign or Lumineers or Zoom tooth whitening, and therefore I think the name means nothing to the public at large." (General dentist)
• "Few people know (or can remember) what a ‘CEREC’ is. Quite frankly, because it is a stupid acronym! Almost all people understand what a single visit crown is! If a company wishes to capture the market for this, then provide a moniker to do so.” (Nevada dentist)

Read more: Cerec Dentists Split over its Dental Marketing Value

Two out of three dentists think that the current publicity is just a tempest in a teapot, while the remainder expect it to be the next big health scandal.

Read more: Dental Lab Safety Concerns

The US government employs several million individuals. As their employer, it’s the government’s job to provide health care coverage to all of these people: soldiers and politicians, maintenance workers and administrators.

Health care benefits for federal employees are managed through the U.S. Office of Personnel Management (OPM). There are seven insurance carriers that provide supplemental dental and vision benefits under the Federal Employees Dental and Vision Insurance Program (FEDVIP). Four of these are nationwide plans, and the other three provide coverage in certain regions.

• Aetna Life Insurance Company
• Government Employees Health Association, Inc. (GEHA)
• MetLife Inc.
• United Concordia Companies, Inc.
• Group Health, Inc. (New York state area)
• CompBenefits (Southeastern US)
• Triple-S, Inc. (Puerto Rico)

I have heard that one of these dental insurance companies has been soliciting bids from offshore dental laboratories. They’re looking to provide a low-cost product option to their network of providers, and it’s nearly impossible to compete with the prices offered by some foreign labs. ($29 dental crowns from China, anyone?)

There are any number of reasons why this might be cause for concern, but chief among them is the Buy American Act. Passed in 1933, this legislation states that the US government should preferentially purchase American products over foreign-made goods. Though exceptions can be made for price or quality issues, the basic principle is that America’s government should patronize American businesses whenever possible.

With reports surfacing that some dental crowns and bridges may be contaminated with lead, there are also health concerns about outsourcing dental restorations. The FDA doesn’t directly regulate overseas labs, and the National Association of Dental Labs warns that there are significant holes in the FDA’s oversight of dental lab manufacturing.

And yet we have GEHA shopping for cut-rate bids from foreign dental labs… Am I the only one who sees a problem here?

Post your own comments

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!

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.

The relationship between dentists and their dental labs is a close one – but is it close enough?

The other shoe has dropped. The lead scandal, a story that The Wealthy Dentist has been covering for the last two months, has now gone national. ABC’s Good Morning America ran a segment about this potential crisis on May 8th. Doctor, you better have your story straight when you patients start asking you where your lab work in being done.

Dental labs have been in the spotlight due to the recent scare over lead apparently finding its way into dental restorations such as crowns and bridges. Dentists are realizing that they are ethically (and possibly legally) responsible for the quality of their dental lab’s work.

There are a number of holes in the current system. Allow me to point out just a few…

Start at the beginning

Once upon a time, would-be dentists studied alongside would-be dental technicians. The two professions are inextricably connected, and each would do well to understand the needs of the other. How better to foster this relationship than by educating students together?

Today, however, that is certainly not the case. At most schools, dental students and lab students have little to no exposure to each other. The communication gap that begins in school tends to continue into the working world.

“Most dentists don’t meet a technician until after they graduate and that’s criminal. The pre-clinical students and dental laboratory technology students are able to learn from each other, which helps them hone the skills they have and build new ones.”
- Bob Schneider, DDS, University of Iowa Hospitals and Clinics Professor (Journal of Dental Technology, June/July 2006)

Bridge the communication gap

One of the biggest complaints dental lab technicians have about dentists is that they often don’t give the lab all the information they’re supposed to. A proper prescription for a dental prosthesis includes detailed information about the materials to be used in its construction. When the dentist doesn’t provide all the details, it’s up to the technician to make these important decisions.

“Most dentists rely on the dental technician to choose the materials needed for the fabrication of the prosthesis. With lack of adequate information, all too often the design, fabrication, and completion of the case is left up to the technician. Therefore, our results indicate an apparent trend to which technicians are left to make crucial decisions for dentists.”
- Z. Afsharzand, DMD et al. (from the Journal of Prosthodontics, Vol 15. No 2 March-April 2006 pgs 123-28)

Know your partners

One dentist will have been working with the mom-and-pop dental lab down the street for thirty years. Another will use a major domestic lab after personally visiting the premises. Another will prefer the US-based chain with the lowest prices. Another will go online to find a Chinese lab that offers crowns for $39.95.

The dentist’s relationship with his or her lab isn’t something the patient can see. It’s not even something most patients would think to ask about. But even if it’s invisible to the patient, it’s likely to be the factor that best predicts the quality of the dental work they receive.

Patients deserve disclosure

In the US, dentists are not required to tell patients if their dental prosthetic was manufactured outside of the country. In fact, dental labs are not always required to tell dentists where the device was manufactured. (And since many US labs use partners overseas, a domestic return address is no guarantee.)

However, expect the laws to start changing soon. A number of states are already considering legislation mandating that labs inform dentists and/or dentists inform patients of work fabricated outside of the country. In Canada, for example, patients must sign an informed consent form before receiving any foreign dental work.

Keep on working

It may be as long as year before the ADA announces the results of their testing. Perhaps it’s a big fuss over nothing; perhaps we’re all slowly dying of lead poisoning. I can’t predict what the science will say. But I can definitely predict this: you, the dentist, are going to be held responsible for your dental lab work. Here’s hoping you can be proud to stand by your restorations.

Post your comments 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.

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.

Post your comments on this story

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.

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.

Learn more – Plus, click here to post your comments on this story.