Dental lab registration: what does it mean?
In fact, according to the 2008 Survey on the Use of Dental Labs, conducted by the ADA Health Policy Resources Center, more than half of dentists polled—53 percent—did not know if dental labs were regulated by their state’s dental practice act. More than 86 percent of respondents didn’t know if the federal government regulated dental labs.
For the record, laws in six states require dental labs to register with the state dental board: Texas, Kentucky, Florida, South Carolina, Pennsylvania and Oklahoma. Bills in three other states have been filed or are pending, and bills in three more states are in development either by the state dental laboratory association, dental society or both.
The U.S. Food and Drug Administration requires registration for dental labs that operate overseas, serve as the initial importer for a foreign laboratory, conduct repackaging services or manufacture sleep apnea/snoring and other specific orthodontic appliances.
Foreign labs manufacturing dental restorations have to register with the FDA in order for their products to be let into the United States. Domestic labs are not required to register with the FDA. Although the FDA has the authority to inspect any dental lab manufacturing in the United States, registered or unregistered, in this country or abroad, being registered is more likely to trigger an inspection of a domestic lab because its location is established.
“A registered lab can step up to the plate and say, ‘Come in and inspect me. I’m proud of the work I do. I only use FDA-approved materials and disclose those to the dentist,’” said Dr. Bill D’Aiuto, chair of the Council on Dental Practice’s Subcommittee on the Future of Dental Laboratory Technology.
The National Association of Dental Laboratories says registration allows for clear communication channels between dental labs, dental manufacturers and the FDA should there be a recall on dental materials or equipment related to a health or safety issue that could ultimately have an impact on dentists and/or their patients.
Registering a dental lab goes further than getting a sign-off on the operation. It also shows dentists the lab is operating under high standards, Dr. D’Aiuto said.
“It says we are willing to set ourselves up to scrutiny to allow the dentists to know that we want to set ourselves apart, that we are compliant to state regulations and minimum standards,” Dr. D’Aiuto said. “I think it’s a badge of courage, if nothing else, and a badge that says we fully comply so therefore we’re safe to use.”
Even in Dr. D’Aiuto’s home state of Florida, where registration is required, he said there are bootleg dental labs that circumvent the government and operate outside of state law.
Texas is another state that requires dental labs to be registered. Dr. Craig Armstrong, a member of CDP and the Subcommittee on the Future of Dental Laboratory Technology, said when he graduated dental school, he received a list of all of the registered labs.
“It’s a way to track each of the dental labs that perform services in the state of Texas,” Dr. Armstrong said. “It’s quality assurance for the dentist.”
The Dental Laboratory Certification Council in Texas advises the state dental board on the dental lab industry, Dr. Armstrong said.
“If there’s an issue that arises within a laboratory, you’ve got your peers looking at it and making recommendations to the state dental board,” Dr. Armstrong said.
Texas labs also have to meet certain assessments and requirements through the Texas State Board of Dental Examiners, and the certified dental technicians working in the labs must complete continuing education hours each year.
Dr. Armstrong says that point-of-origin laws in Texas require dental labs there to disclose the lab that fabricated any dental device created there and the materials used to manufacture it.
In 2007, the American Dental Association House of Delegates adopted policy urging constituent dental societies to pursue legislation or voluntary agreements to require that a domestic dental laboratory which subcontracts the manufacture of dental prostheses notify the dentist in advance when such prostheses components or materials indicated in the dentist’s prescription are to be manufactured or provided, either partially or entirely, by a dental laboratory outside the United States or at any domestic ancillary dental laboratory.
“I think a lot of states could look at Texas and see how we do things. We have a pretty good relationship with our dental lab technicians as a whole,” Dr. Armstrong said. “I think registration just elevates the profession of laboratory technicians.”
“A greater measure of patient safety and thereby a greater measure of professionalism within dental laboratories can be measured through registration,” Dr. D’Aiuto said. “The ultimate goal of registration would be to assure dentists and patients that they are getting top services and products from dental labs.”