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.
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.