3Shape announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) premarket notification clearance for its Dx software.
The notification allows the software to be commercially available in the U.S. to aid in the diagnosis of key oral health conditions and the assessment of changes in teeth and gums in adult patients. The clearance applies to its Dx Plus and Dx Standard.
Dx Plus, which is exclusively compatible with 3Shape Trios 6 scans, is an AI-assistive software that aids in detecting key oral health conditions, including surface and proximal caries, plaque, tooth wear, and gingival recession. Dx Standard, which is compatible with all 3Shape Trios models except Trios Core, can help dentists manually track and quantify changes to teeth.
Since 2025, Dx software has been sold and used by clinicians in Europe, the Middle East, Africa, South America, and Canada.
