Parker Waichman LLP

FDA Issues Guidance For Dental Cone-Beam CT Scans

The U.S. Food and Drug Administration (FDA) just issued new guidance for dental cone-beam CT scans. Cone-beam computed tomography systems (CBCT) are a variation of traditional computed tomography (CT) systems. The CBCT systems are used by dental professionals and rotate around the patient. These systems capture data via a cone-shaped X-ray beam. Data then reconstruct […]

The U.S. Food and Drug Administration (FDA) just issued new guidance for dental cone-beam CT scans.

Cone-beam computed tomography systems (CBCT) are a variation of traditional computed tomography (CT) systems. The CBCT systems are used by dental professionals and rotate around the patient. These systems capture data via a cone-shaped X-ray beam. Data then reconstruct a three-dimensional (3D) image of the patient’s dental area (teeth); oral and maxillofacial region (mouth, jaw, and neck); and ears, nose, and throat (ENT).

CBCT systems have been sold in the U.S. since the early 2000s, and use of these systems is on the rise by radiologists and dental professionals. Used for dental implant planning; visualization of abnormal teeth; evaluation of the jaws and face; cleft palate assessment; and dental caries (cavities), endodontic (root canal), and dental trauma diagnoses, the systems provide a fast, non-invasive method to answer various clinical questions. CBCT images provide 3-D, rather than the traditional 2-D information provided by conventional X-ray.

The new FDA guidance also involves the creation of a new Web page meant to provide clinicians and patients with the most current information on the health and safety of CBCT, explained DrBicuspid.com. According to an FDA spokesman, the “Dental Cone-beam Computed Tomography” web page is new to the Radiation-Emitting Products site. The site will also enable clinicians, patents, and patients to view industry accurate information that will help ensure CBCTs are performed when appropriate and “optimized.” To be optimized means that the exposure settings chosen are based on the “As Low As Reasonably Achievable” (ALARA) principle, said DrBicuspid.com.

“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,” the FDA states on its new web page. “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.”

Earlier this year, the FDA released a pediatric x-ray imaging web page and draft guidance so that the manufacturers of x-ray imaging devices would be better able to consider pediatric safety when designing new equipment, Dr.Biscupid.com explained.

Among other things, the FDA states that it and the American Dental Association (ADA) recommend clinicians perform dental X-ray examinations, including dental CBCT, only when necessary for disease diagnosis or treatment. While the clinical benefit of a medically appropriate X-ray imaging exam does outweigh its radiation risk, clinicians should ensure measures are in place to minimize this risk.

The American Academy of Oral and Maxillofacial Radiology, the International Congress of Oral Implantologists, and the American Association of Endodontists all released position statements and professional guidelines for CBCT use in dentistry, said DrBicuspid.com.

Detailed information on FDA guidance is accessible here.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Ashley L worked with me kept me updated and informed on everything that was going on with my case in a timely and professional manner.
Larry Lutes
3 years ago
5 Star Reviews 150
Working with Julia & Joanne at Parker & Waichman. Julia and Joanne were very helpful throughout the process and took good care of me. All of my questions were always answered and they always communicated with me, phone calls were always returned right away if they could not answer. I was recommended by my friend and would definitely recommend them. Thank you for all of your help Julia, Joanne and all of the Parker Waichman family.
Tusha Ramsaroop
5 years ago
5 Star Reviews 150
Parker Waichman has been very helpful in handling all aspects of my case to a successful resolution. They are very skilled in what they do and I was extremely impressed with the professionalism of the paralegal Benita Rollins who kept me informed every step of the way, was very efficient and followed up on every detail. I would highly recommend Parker Waichman for your legal needs.
Herbert Miller
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038