Dtx 2 D Findings Image (1)

510(k) clearance of pathological dental findings AI on 2D intraoral x-ray images

April 28, 2023
DEXIS DTX Studio Clinic is the first software medical device to support six types of pathological dental findings, fully integrated into imaging software.

DEXIS announces FDA 510(k) clearance for dental findings AI on 2D intraoral x-ray images. As the next generation of DEXIS software, DTX Studio Clinic now offers the first and only imaging solution with six types of pathological dental findings on periapical and bitewing intraoral radiograph images and is fully integrated into on-premise imaging software. DTX Studio Clinic is an imaging acquisition, diagnosis, and treatment planning software that is part of the DTX Studio suite of products used by more than 10,000 dental offices.

DTX Studio Clinic screens dental radiographs and annotates suspected areas of interest, supporting the clinician in making informed decisions. These clinical conditions include these types of pathological dental findings: caries, discrepancy at margin, root canal defects, periapical radiolucency, bone loss, and calculus. With DTX Studio Clinic, clinicians can present patients with a more comprehensive view of the diagnosis and treatment plan, building patient understanding and trust while also driving practice efficiencies.

This clearance further complements a series of enhanced AI-powered functionalities in DTX Studio Clinic. In 2017, Envista obtained FDA clearance for its AI-driven 3D virtual tooth setup algorithm. In 2020, a further clearance was received for automatic tooth position identification and automated sorting of full-mouth x-ray series. In 2022, the FDA cleared the fully automated mandibular nerve tracing on CBCT scans. These continual enhancements and innovations have earned DTX Studio Clinic back-to-back Cellerant Best of Class Technology Awards, as well as high praise from doctors.

“DEXIS is empowering practices to embrace digital dentistry for improved efficiencies and predictable patient outcomes,” says Amir Aghdaei, CEO of Envista. “With our newest release of DTX Studio Clinic, featuring enhanced built-in AI features like the pathological dental findings, practices now have an enhanced solution for their digital workflow—from diagnosis to treatment planning to delivery of care.”

Sign up to be the first to try DTX Studio Clinic AI 2D dental findings at dexis.com/earlyaccess.

To learn more about DEXIS, visit their website.

Source: Press release dated April 20, 2023

Sponsored Recommendations

Clinical Study: OraCare Reduced Probing Depths 4450% Better than Brushing Alone

Good oral hygiene is essential to preserving gum health. In this study the improvements seen were statistically superior at reducing pocket depth than brushing alone (control ...

Clincial Study: OraCare Proven to Improve Gingival Health by 604% in just a 6 Week Period

A new clinical study reveals how OraCare showed improvement in the whole mouth as bleeding, plaque reduction, interproximal sites, and probing depths were all evaluated. All areas...

Chlorine Dioxide Efficacy Against Pathogens and How it Compares to Chlorhexidine

Explore our library of studies to learn about the historical application of chlorine dioxide, efficacy against pathogens, how it compares to chlorhexidine and more.

Enhancing Your Practice Growth with Chairside Milling

When practice growth and predictability matter...Get more output with less input discover chairside milling.