There is a growing presence of direct to the consumer (DTC) dental laboratory services, where patients are instructed in how to independently take their own impressions and order products such as mouth guards, snoring appliances, teeth whitening trays and bleaching products, partial dentures, veneers and aligners. Direct to consumer laboratory services eliminate the role of the dentist in diagnosing the patient’s oral health needs, developing a treatment plan to best meet those needs, and safely managing treatment throughout the course of care. Self-delivered, unsupervised dental treatments have the potential to cause damage and irreversible complications for patients.
Every state has regulations that require dentists and hygienists to be licensed in order to provide patient care. The level of oversight for dental assistants varies by state and, while dental assistants may or may not be licensed or registered by the state, they are required to perform their duties under the supervision of a licensed dentist. State dental practice acts define the scope of practice for dentists, hygienists, and licensed or registered dental assistants.
However, dental laboratory technicians and businesses are generally not licensed. While the ADA maintains policy encouraging state boards to register dental laboratories, only seven states currently require dental laboratory registration. No states require registration of dental laboratory technicians.
The traditional role of a dental laboratory has been to manufacture prosthetics or devices in accordance with the written directives (or instructions) provided by a licensed dentist. ADA's policy, Statement on Prosthetic and Appliance Care and Dental Laboratories, specifies that "the dentist-provider is ultimately responsible for the patient's care, the Association believes that he or she is the only individual qualified to accept responsibility for prosthetic care." Dentists are responsible for all aspects of the manufacture of prosthetic devices through ordering or prescribing the prosthetic device, receiving the notifications of materials and country of origin, and delivering prosthetics to patients.
A policy on do-it-yourself teeth straightening was adopted by the ADA’s House of Delegates in 2017 and states ADA's position on self-directed orthodontic treatment. In October 2018, the ADA adopted a policy on direct to consumer dental laboratory services. The policy states that the ADA strongly discourages the practice of direct to the consumer dental laboratory services because of the potential for irreversible harm to patients.
It’s also worth noting that dental prosthetics, such as aligners, partial dentures and snoring appliances are considered medical devices by the U.S. Food & Drug Administration (FDA). In case of problems, the FDA encourages consumers as well as health care professionals to utilize and submit the MedWatch voluntary reporting form to help improve safety by bringing attention to particular issues. More general information about the FDA medical device reporting program can be found here.