News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears 3Shape Dx AI Software for Reading Intraoral Scans

The Danish company's software, sold abroad since 2025, aids dentists in diagnosing caries, tooth wear, gingival recession and plaque from TRIOS scanner data.

By News DeskApril 28, 20262 min read
A dental chair and equipment in a dentist's office
A dental chair in a dentist's office in North Carolina. Not a 3Shape product or a clinic using the software described in this article. Harrison Keely, CC BY 4.0, via Wikimedia Commons · CC BY 4.0
FDA cleared510(k) · K260082FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • 3Shape said on April 27 that the FDA cleared its Dx software after a review completed April 10; FDA records list the device as TRIOS Dx (R1), K260082.
  • The clearance covers Dx Plus, AI-assistive software that works only with TRIOS 6 scans, and Dx Standard, which tracks changes in teeth manually.
  • The FDA classified it as a Class II prescription dental image analyzer, and 3Shape said it went on sale in the US the same day.

3Shape said on April 27 that the U.S. Food and Drug Administration has cleared its Dx software, which analyzes scans from the company's TRIOS intraoral scanners to help dentists diagnose oral health conditions, according to the Copenhagen-based company's press release distributed through Cision.

FDA records show the device, listed as TRIOS Dx (R1), was found substantially equivalent under 510(k) number K260082 on April 10, 2026, after the submission was received on January 12. The agency's clearance letter classifies it as a Class II dental image analyzer under 21 CFR 872.1770, product code SHQ, and marks it for prescription use.

What the clearance covers

According to the indications for use, TRIOS Dx is intended as an aid in the diagnosis of oral health conditions and the assessment of changes in teeth and gingiva. The FDA document lists four conditions: caries, tooth wear, gingival recession and plaque. 3Shape said the software is for use by qualified dental professionals in dental clinics with adult patients.

The clearance applies to both versions of the product, the company said. Dx Plus is AI-assistive software that aids in detecting surface and proximal caries, plaque, tooth wear and gingival recession, and works only with scans from the TRIOS 6. Dx Standard lets dentists manually track and quantify changes to a patient's teeth, and is compatible with all TRIOS models except the TRIOS Core.

3Shape said dentists can use the software during routine checkups to show patients their oral health conditions on screen and monitor them over time.

"Receiving FDA 510(k) clearance for Dx underscores our commitment to responsible innovation and to delivering digital solutions that meet the highest clinical and regulatory standards," said chief executive Jacob Paulsen.

Launch

The company said Dx has been sold and used by clinicians since 2025 in markets including Europe, the Middle East, Africa, South America and Canada. It said the software became available in the US on the day of the announcement through resellers and 3Shape representatives, with trials offered to eligible customers through its webshop.

3Shape, founded in Denmark in 2000, said it employs more than 2,200 people and serves customers in more than 100 countries. Private equity fund EQT has been a shareholder since 2021, according to the release. The company did not disclose US pricing or the performance data submitted to the FDA, and the agency's posted document for K260082 does not include a 510(k) summary of test results.

Sources

  1. 3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software, 3Shape (Cision), April 27, 2026
  2. 510(k) Premarket Notification K260082: TRIOS Dx (R1), FDA, April 10, 2026
  3. K260082 clearance letter and indications for use, FDA, April 10, 2026