Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices (such as denture teeth and implants) and therapeutic devices (such as orthodontic devices). The FDA regulates these products as medical devices and they are therefore subject to FDA’s good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants.
Certification in the dental laboratory profession is strictly voluntary. Laboratories who have taken the extra steps to become certified represent the top of their field. The most easily obtainable certification is the CDL (Certified Dental Laboratory). A Certified Dental Laboratory has met standards in personnel skill, laboratory facility maintenance, training, infection control, tracking mechanisms and good business and manufacturing practices. The certification is based on a third party review of photos of the facility. The next tier for certification is DAMAS (Dental Appliance Manufacturers Audit Scheme). DAMAS requires a third party on-site inspection. Based on international standards for the manufacturing of medical devices, the DAMAS certification ensures the lab environment operates in such a way as to ensure product and patient safety. It provides a formula for improved documentation of many aspects of dental lab (dental lab equipment) activity (from dental prescriptions to material traceability). DAMAS standards mirror the FDA's quality system and good manufacturing practice standards, which all domestic dental laboratories must comply with.
The National Association of Dental Laboratories has launched a Web site to inform consumers concerned about recent reports of lead contamination in dental crowns imported from overseas. The Web site, http://www.whatsinyourmouth.us, provides consumers an opportunity to contact the association's staff with questions regarding the news reports about the potential for such products to be contaminated with harmful amounts of lead.
Numerous news outlets have reported on this issue since Feb. 27, when WBNS-TV in Columbus, Ohio, reported a confirmed case of a victim made sick by lead contamination from an imported dental restoration. The station further reported that an independent analysis of dental crowns imported from offshore dental laboratories found some products to be contaminated with dangerous levels of lead.
The case confirms long-standing concerns of the National Association of Dental Laboratories, which for years has urged federal and state regulators to implement more stringent regulation to protect patients receiving dental restorations.
The National Association of Dental Laboratories, based in Tallahassee, Fla. - the leading trade group for the $8 billion U.S. dental-restoration products industry - has been on record since 2003 supporting federal and state regulation to assure patients their restorations are safe for use, regardless of where they are manufactured. Through public advocacy and outreach, the Association has worked with the U.S. Food & Drug Administration, state health officials and the dental industry to support: