Dental AI software secures FDA clearance

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Dental technology company 3Shape has received FDA approval for Dx Software, its dental AI platform. 

The FDA’s 510(k) Premarket Notification allows the software to be commercially available and be utilized by dental clinics in the U.S., according to an April 28 news release from 3Shape. 

The Dx Software aids dentists in the diagnosis of oral health conditions and the assessment of changes in teeth and gingiva in adult patients.

Dx Plus can help detect conditions including surface and proximal caries, plaque, tooth wear and gingival recession. Dx Standard manually tracks and quantifies changes in patients’ dentition. 

The technology has been used by providers across international markets including Europe, South America and Canada, the release said. 

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