General Dentistry Concepts: Laboratory technology
Dental laboratories manufacture and customize numerous products to assist the dentist in providing oral health care. Examples of these products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription which is provided by a licensed dentist when manufacturing these items. This also includes prosthetic devices such as dentures and implants in addition to therapeutic or orthodontic devices. The FDA regulates these products as they are considered medical devices and are subject to the FDA's good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, these products are exempt from other manufacturer registration requirements. Some of the most common restorations manufactured in dental labs include crowns, bridges, dentures and dental implants. Dental implants are one of the most advanced technologies in dentistry.
Certification in the dental laboratory profession is considered to be voluntary. Laboratories which take the extra steps required to become certified are considered the top of their field. The easiest certification to obtain is the CDL (Certified Dental Laboratory). A CDL has met standards in the following areas: personnel skill, training, infection control, tracking mechanisms and good business and manufacturing practices. The certification is awarded based on a third party review of photos from the facility. The next level of certification is DAMAS (Dental Appliance Manufacturers Audit Scheme). The DAMAS requires an on-site inspection conducted by a third party. Based on international standards for the manufacturing of medical devices, the DAMAS certification ensures the lab environment operates in a way that ensures product and patient safety. It also provides a formula to improve documentation of various aspects of dental lab activity which can range from dental prescriptions to material traceability. The DAMAS standards align with 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 is through ISO "International Organization for Standardization". ISO develops their standards through the agreement of organizations from 161 countries. ISO members provide a global representation from both the public and private sectors. The goal of ISO standards is to represent the best interests and needs of the broader global society. ISO 9001, as an example, is a set of standards used for quality management systems. ISO 13485 is a set of standards which represent the requirements for a comprehensive management system for designing and manufacturing medical devices. The standard places an emphasis on meeting regulatory requirements and managing risk in order to ensure the production of safe design and distribution of medical devices. Product documentation must be thorough and follow the complete life cycle of product design, manufacturing and post-delivery.
National Association of Dental Laboratories
In 1951, The National Association of Dental Laboratories (NADL) was formed in the United States following the merger of Dental Laboratory Institute of America and the American Dental Laboratory Association. NADL became a federation of state commercial dental laboratory associations.
From 1968 to 1971 the association was known as the National Association of Certified Dental Laboratories before it changed back to its original name. The NADL’s mission is to be an advocate for the dental laboratory technology industry by promoting professionalism, setting technical standards and providing valued services to its members. NADL aims to uphold and advance the dignity, honor and efficiency of those engaged as operators of dental laboratories, to advance their standards of service to the dental profession and to establish cooperation among its members.