On this webpage, the FDA is providing:

information about the use of cone-beam computed tomography in dentistry particularly in the pediatric population,

information for patients, parents and health care providers to help reduce unnecessary radiation exposure from dental cone-beam computed tomography, and

resources for manufacturers of dental cone-beam computed tomography devices.

Description

Cone-beam computed tomography systems (CBCT) are a variation of traditional computed tomography (CT) systems. The CBCT systems used by dental professionals rotate around the patient, capturing data using a cone-shaped X-ray beam. These data are used to reconstruct a three-dimensional (3D) image of the following regions of the patient’s anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw, and neck); and ears, nose, and throat (“ENT”).

Cone-beam computed tomography system.

Uses

Dental CBCT systems have been sold in the United States since the early 2000s and are increasingly used by radiologists and dental professionals for various clinical applications including dental implant planning, visualization of abnormal teeth, evaluation of the jaws and face, cleft palate assessment, diagnosis of dental caries (cavities), endodontic (root canal) diagnosis, and diagnosis of dental trauma.

X-ray imaging, including dental CBCT, provides a fast, non-invasive way of answering a number of clinical questions. Dental CBCT images provide three-dimensional (3-D) information, rather than the two-dimensional (2-D) information provided by a conventional X-ray image. This may help with the diagnosis, treatment planning and evaluation of certain conditions.

Although the radiation doses from dental CBCT exams are generally lower than other CT exams, dental CBCT exams typically deliver more radiation than conventional dental X-ray exams. Concerns about radiation exposure are greater for younger patients because they are more sensitive to radiation (i.e., estimates of their lifetime risk for cancer incidence and mortality per unit dose of ionizing radiation are higher) and they have a longer lifetime for ill effects to develop.

The FDA has launched a pediatric X-ray imaging website that provides specific recommendations for parents and health care providers to help reduce unnecessary radiation exposure to children. The FDA’s Center for Devices and Radiological Health defines the ages of the pediatric population as birth through 21 years.

Information for Patients and Parents

The American Dental Association (ADA) and the FDA recommend that clinicians perform dental X-ray examinations, including dental CBCT, only when necessary for the diagnosis or treatment of disease. The clinical benefit of a medically appropriate X-ray imaging exam outweighs the small radiation risk. However, efforts should be made to help minimize this risk.

The FDA also recommends that for all X-ray imaging procedures, including dental CBCT, patients and parents of children should:

Information for Dental Professionals

Dental CBCT should be performed only when necessary to provide clinical information that cannot be provided using other imaging modalities.

As stated in FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, the FDA recommends imaging professionals follow the principles of justification and optimization in the protection of patients undergoing radiological examinations. The FDA recommends that dental professionals:

Discuss the rationale for the examination with the patient and/or parent to ensure a clear understanding of benefits and risks.

Reduce the number of inappropriate referrals (i.e., justify X-ray imaging exams) by: determining if the examination is needed to answer a clinical question, considering alternate exams that use less or no radiation exposure, and reviewing the patient's medical imaging history to avoid duplicate exams.

Use exposure settings for dental CBCT exams that are optimized to provide the lowest radiation dose that yields an image quality adequate for diagnosis (i.e., radiation doses should be "As Low as Reasonably Achievable"). The technique factors used should be chosen based on the clinical indication, patient size, and anatomical area scanned, and the equipment should be properly maintained and tested.

Additional information for health care providers on appropriate and safe use of dental X-ray imaging exams includes:

Information for Industry

Dental CBCT systems are medical devices that are also radiation-emitting electronic products. The FDA regulates manufacturers of dental CBCT devices through the Electronic Product Radiation Control (EPRC) and medical device provisions of the Federal Food, Drug, and Cosmetic Act. Dental CBCT systems are classified under 21 CFR 892.1750.

For more information on bringing an X-ray imaging system to market and for post-market requirements see:

FDA's webpages on Computed Tomography and Medical X-Rays provide more detailed lists of industry resources relevant to dental CBCT systems.

On November 28, 2017, the FDA issued Final Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications to encourage manufacturers to consider the radiation safety of pediatric populations in the design of new X-ray imaging devices, including dental CBCT systems. On July 16, 2012, the FDA held a public workshop to discuss the draft guidance. Participants provided recommendations specific to dental cone-beam CT scanners. More information about the meeting (including archived webcast and presentation slides) are available on the workshop website, Device Improvements for Pediatric X-ray Imaging.

Required Reports for Industry