Surround Medical Systems has received the US Food and Drug Administration (FDA) 510(k) pre-market approval for its patented PORTRAY dental imaging system.

The FDA 510(k) pre-market approval allows the commercial sale and use of the PORTRAY system as a 2D diagnostic, 3D tomosynthetic and 2D synthetic imaging tool.

Also, the approval allows the use of the device as an adjunctive tool for producing diagnostic dental radiographs of teeth, jaw, and other oral structures.

PORTRAY is said to be the first FDA approved dental system that features tomosynthetic, or 3D Tomo, imaging, intended for intraoral use by dentists.

Surround Medical Systems president and CEO David LaVance said: “Dentists have been waiting for a major improvement to intraoral dental imaging for more than two decades.

“The PORTRAY system provides dentists with an intraoral 3D dental imaging system that will allow the dentists to provide a higher level of care for patients by detecting cavities and fractures that would otherwise go undetected by current 2D intraoral dental imaging systems.

“The PORTRAY system has the potential to substantially change and improve dental techniques and provide patients better outcomes and improved health.”

The company said that intraoral 2D imaging has been the X-ray method used by dentists for more than five decades, to detect caries or cavities.

Unlike traditional X-ray systems, its PORTRAY system provides dentists with the ability to visualise tooth decay in its earlier stages.

Also, the system allows dentists to visually separate contacts and examine the entire volume of the tooth, and reveal conditions that were previously invisible or obscured.

The system deploys multiple X-ray beams to generate imaging slices, leveraging the same procedural techniques as in 2D machines currently installed in dental offices.

The imaging slices are reconstructed using the company’s software, which creates 3D tomosynthetic and 2D synthetic images that are previously available.

Surround Medical Systems designed the PORTRAY system based on carbon nanotube-based X-ray technologies patented by the University of North Carolina at Chapel Hill (UNC).

It intends to assemble and distribute the PORTRAY system from its facility in Morrisville, North Carolina, and provide it to dental practices in the fourth quarter of 2021.