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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
A crown is a traditional form of head adornment, or hat, worn by monarchs as a symbol of their power and dignity. A crown is often, by extension, a symbol of the monarch's government or items endorsed by it. The word itself is used, partic ...
,
bridges
A bridge is a structure built to Span (engineering), span a physical obstacle (such as a body of water, valley, road, or rail) without blocking the way underneath. It is constructed for the purpose of providing passage over the obstacle, whic ...
,
dentures
Dentures (also known as false teeth) are prosthetic devices constructed to replace missing teeth, and are supported by the surrounding soft and hard tissues of the oral cavity. Conventional dentures are removable (removable partial denture or ...
, and
dental implant
A dental implant (also known as an endosseous implant or fixture) is a prosthesis that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture, or facial prosthesis or to act as an orthodonti ...
s. Dental implants is one of the most advanced dental technologies in the field of dentistry.
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, 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
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...
standards, which all domestic dental laboratories must comply with.
The highest level of manufacturing certifications available to dental laboratories are through the
ISO
ISO is the most common abbreviation for the International Organization for Standardization.
ISO or Iso may also refer to: Business and finance
* Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007
* 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
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 90 ...
is a set of standards for quality management systems.
ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive ...
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.
National Association of Dental Laboratories
The National Association of Dental Laboratories (NADL) was formed in the United States in 1951 after the merger of Dental Laboratory Institute of America and the American Dental Laboratory Association. It became a federation of state commercial dental laboratory associations. This merger took place in
Chicago
(''City in a Garden''); I Will
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and then, in 1952, NADL established its headquarters offices in
Washington, D.C.
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, which were moved to
Tallahassee
Tallahassee ( ) is the capital city of the U.S. state of Florida. It is the county seat and only incorporated municipality in Leon County. Tallahassee became the capital of Florida, then the Florida Territory, in 1824. In 2020, the population ...
,
Florida
Florida is a state located in the Southeastern region of the United States. Florida is bordered to the west by the Gulf of Mexico, to the northwest by Alabama, to the north by Georgia, to the east by the Bahamas and Atlantic Ocean, and to ...
later in 2001.
The association was known as the National Association of Certified Dental Laboratories from 1968 to 1971 when it changed back to its original name. Its mission is to be the recognized advocate for the dental laboratory technology industry by promoting professionalism, setting
technical standard
A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, ...
s and providing valued services to its membership. The stated purpose of NADL is 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.
NADL offers several benefits to its members and one of such benefits is that it promotes high standards and aims to work as a unified voice for the dental laboratory trade. NADL establishes alliances with professional businesses to benefit its members with either discounts or services. Members also benefit from NADL's educational programs ranging from seminars, conferences, materials, the NADL University which offers a Certificate in Dental Laboratory Management, to the Wealth of Knowledge Videotape Library. These programs inform and educate NADL members on topics such as production, marketing, and promotion, and also serve as continuing education credits. Furthermore, this association offers the NADL Pillar Scholarship aimed to provide qualified dental technicians the opportunity to take the necessary examinations to complete the Certified Dental Technician examination process.
NADL also has its set of communications tools to keep its members informed about the industry trends. Two examples are the Journal of Dental Technology (JDT), a journal published 9 times a year, and JDT Unbound, a mail newsletter that includes regular updates.
Its
Board of Directors
A board of directors (commonly referred simply as the board) is an executive committee that jointly supervises the activities of an organization, which can be either a for-profit or a nonprofit organization such as a business, nonprofit organiz ...
comprises 14 members and its current President is Robert Savage. NADL also has an independent board, the National Board for Certification in Dental Laboratory Technology, founded in 1955 as an independent certification organization. It administered the first Certified Dental Technician (CDT) tests in October 1958 and awarded the first CDT certificates in March of the following year.
A wide range of institutions offer
associate degree
An associate degree is an undergraduate degree awarded after a course of post-secondary study lasting two to three years. It is a level of qualification above a high school diploma, GED, or matriculation, and below a bachelor's degree.
The fi ...
programs to become a technician. In addition, an interested person can complete an apprenticeship program that lasts for five years. After the apprenticeship or associate degree has been finished, the person will need to pass an exam that is administered by the National Board for Certification in Dental Laboratory Technology.
CDTs can retain certification if they apply to the NBC every year for renewal and prove they have complied with the local laws governing their work and undergone continuing technical education. They are also required to pay a
renewal fee.
NADL regulations
It is in NADL best interests to protect the patients' health and assure their restorations are safe for use. To fulfill this objective, NADL has supported federal and state regulations since 2003 and has worked close with the U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), state health officials and the dental industry as well. It has also developed regulatory guidelines aimed to be a basic standard of regulation. Although its main objective is to benefit the general public it is also intended to be effective for the dental technicians and the dental industry. One of the requests from NADL to the FDA has been to protect patient's safety. In this sense, the Association intends that the source of dental devices be disclosed to the patient.
NADL has expressed its support to establish mandatory certification and continuing education for dental technicians dedicated to restoration manufacture; mandatory registration of all dental laboratories with the competent authority; mandatory documentation of those materials used in any restoration and their point of origin; as well as mandatory documentation of the mentioned items in the patient's dental records.
In their Guidelines for Establishing Statutory Regulation, NADL has noted that certification is a way to recognize individuals who have met established qualifications, therefore, they should be the only ones legally acknowledged to use the designated title.
Dental Lab Certification in the UK
All Dental Technicians and Clinical Dental Technicians in the UK are required by law to be registered with the
General Dental Council
The General Dental Council (GDC) is an organisation which regulates dental professionals in the United Kingdom. It keeps an up-to-date register of all qualified dentists and other dental care professionals such as: dental hygienists, dental ther ...
(GDC). The GDC is an organisation which regulates all dentists and dental care professionals, they set and maintain standards in UK dentistry.
Many of those who work for Dental Laboratories are also registered with the
Dental Technologists Association (DTA). The DTA is a professional association representing the interests of dental technicians in the UK.
The GDC ensures that dental professionals have the necessary qualifications and are trained to the necessary levels. Dental technicians must prove their knowledge is up-to-date by taking part in
Continuing Professional Development
Professional development is learning to earn or maintain professional credentials such as academic degrees to formal coursework, attending conferences, and informal learning opportunities situated in practice. It has been described as intensive ...
(CPD).
References
External links
* National Association of Dental Laboratories
* International Organization for Standardization
* Dental Laboratory Career
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Dentistry