Significant Risk Medical Devices – Dental

The Food and Drug Administration has produced a guidance document truly dedicated to the significant and nonsignificant risk medical as well as dental devices. These regulations are required to provide guidance to Institutional Review Boards (IRBs), clinical investigators, and sponsors for determining the difference between the nonsignificant and significant risk devices in the medical field. Significant risk dental devices are investigational devices that represent a potential for serious health risk, welfare, or safety of a patient/subject, or is claimed for sustaining or supporting a human life and presents a serious risk to the safety, health, or the welfare of the patient/subject, or is considered of significant importance with respect to diagnosis, cure, management, and/or disease treatment, or if it presents a potentially serious risk to safety, health, or welfare of a subject. In the dental field, there are six such devices, i.e., absorbable materials, dental lasers, bone morphogenetic proteins, subperiosteal implants, endosseous implants, and temporomandibular joint prosthesis. This chapter discusses these devices, their uses, mechanism of action, benefits on the patient, along with their associated side or adverse effects. Furthermore, their reported investigations (if any) in the literature has been discussed.