Dentsply Sirona Releases FDA-Cleared Dental AI

Dentsply Sirona has launched Smart View – Detect, a U.S. Food and Drug Administration (FDA)-cleared artificial intelligence (AI)-enabled diagnostic aid for detecting teeth with periapical radiolucencies (PARLs) in CBCTs. It’s also CE marked in Europe.

The AI-assisted support feature was engineered to help. Clinicians review CBCT scans more efficiently and clearly when evaluating potential PARLs. These are a common clinical finding—Dentsply Sirona cited research that about 52% of adults have at least one tooth affected. PARLs usually need endodontic treatment, which underscores the need for accurate detection and review.

CBCT imaging is recognized for its diagnostic value but reviewing the depth of information contained in full 3D volumes can feel intimidating in everyday practice. Smart View – Detect aims to help reduce the risk of overlooked findings by visually highlighting areas in CBCT scans where possible PARLs might be present.

An internal multi-reader, multi-case clinical study comparing AI-assisted versus unaided CBCT review showed clinicians using Smart View – Detect increased tooth-level PARL detection sensitivity by about 46% relative to unaided view, without meaningfully increasing false positives.

The clarity provided by the tech can help patients easily understand what their dentist is seeing to support informed, confident, and productive treatment discussions. It doesn’t offer a diagnosis, but its visual presentation can help strengthen understanding, engagement, and trust during consultations.

“Smart View – Detect is designed to support dentists at two important moments—when reviewing complex CBCT data and when explaining findings to patients,” said Wolf-Dieter Perlitz, senior director DS Core at Dentsply Sirona. “By bringing a first of its kind AI-based diagnosis support into DS Core, we continue to advance the value of Connected Dentistry, helping clinicians feel confident in their evaluations, work more efficiently, and communicate more clearly with patients.”

Smart View – Detect is available for both newly installed and existing compatible Dentsply Sirona CBCT systems, including Orthophos S, Orthophos SL, and Axeos. The feature supports all fields of view from 5×5 to 17×11 and works with both newly acquired and historical CBCT scans transferred from Sidexis 4 into DS Core.