DEXIS Announces FDA 510(k) Clearance of pathological dental findings AI on 2D intraoral X-ray images

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

QUAKERTOWN, Pa., April 20, 2023 /PRNewswire/ -- 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 and is part of the DTX Studio suite of products used by over 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 six 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 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 www.dexis.com/earlyaccess.

About DEXIS

DEXIS includes a full portfolio of products including CBCT and Intraoral scanners, our legacy digital sensors and handheld x-ray system and DTX Studio Clinic, the next generation software. This complete digital solution works seamlessly together as well as with other systems to enhance the way you diagnose, plan, and treat patients in your practice. Elevate your patient outcomes with greater confidence — across the patient journey. With DEXIS proven solutions, you'll be able to treat patients from consultation to diagnosis to treatment to surgery and deliver appliances, all with the efficiency that you come to expect with the DEXIS brand you already know. For more information, please visit https://www.dexis.com.

About Envista Holdings Corporation
Envista is a global family of more than 30 trusted dental brands, including DEXIS, Nobel Biocare, Ormco, and Kerr united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers a broad range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

SOURCE DEXIS, LLC