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:
- Any lead in dental prostheses is too much lead.
- 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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