Dental Laboratory

Dental Laboratory

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 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 highest level of manufacturing certifications available to dental laboratories are through the ISO "International Organization for Standardization". The ISO develops standards through the consensus of standards organizations from 161 countries. Members represent both the public and private sectors of countries around the world. ISO standards are thought to represent the best interests and needs of the broader global society. ISO 9001 is a set of standards for quality management systems. ISO 13485 is a set of standards, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It emphasizes meeting regulatory requirements and managing risk in order to ensure the production of safe design and distribution of medical devices. Product documention is thorough and covers the entire life cycle of product design, manufacture and post-delivery. Although not considered a substitute, ISO 13485 will align a dental lab's management system not only with the FDA QS-GMP regulation, but various other regulatory requirements found throughout the world.