3Shape's software for analyzing dental scans and comparing them with previous records has entered the US market.
On April 27, 2026, 3Shape announced US Food and Drug Administration (FDA) 510(k) clearance for its Dx software. The company said the review was completed on April 10. It stated that US sales would begin on the day of the announcement.
Clearance to Support Diagnosis in Adult Patients
The clearance covers use by dental professionals in the clinic to assist in diagnosing oral conditions and assessing changes in adult patients' teeth and gums. It includes both Dx Plus, which provides AI analysis, and Dx Standard, which provides manual tracking.
3Shape said it had been selling Dx since 2025 in regions including Europe, the Middle East, Africa, South America and Canada. This announcement marks the existing product's entry into the US market. The company highlighted showing patients their oral condition on screen and examining changes over time as key uses.
Hardware Compatibility for AI Analysis
Dx Plus supports only scans acquired with TRIOS 6. According to the company's announcement, its analysis assists in identifying cavities on tooth surfaces and between teeth, plaque, tooth wear and gum recession. Gum recession is a condition in which the gumline recedes, exposing the root area of a tooth. This describes the scope of the product's features; it is not a comparison of treatment outcomes.
Dx Standard helps dentists manually track changes and record measurements. It is compatible with TRIOS models other than TRIOS Core. Even under the same Dx name, the configuration differs depending on whether AI analysis is used and which scanner is connected.
Korean-Language Product Information and Availability in South Korea
3Shape's Korean-language website introduces TRIOS 6 and provides ways to request a demonstration and a quote. It presents the scanner, computer and related software together, and identifies the local entity as 3Shape Korea. Prosthodontics, orthodontics, implant dentistry and assessment of tooth condition are listed as uses for the digital images.
For patients, the change is that scan images can serve as material for explaining changes in their condition as well as for discussing treatment. However, the scanner information confirmed in the Korean-language materials should be distinguished from US clearance for Dx sales. The Korean-language product page reviewed does not specify a South Korean clearance or supply schedule for Dx, or patient costs. The start of US sales alone does not establish that the same AI features are immediately available at dental clinics in South Korea.