TRIOS Dx (R1)— 510(k) K260082
Substantially Equivalent3Shape TRIOS A/S
FDA 510(k) clearance K260082 for TRIOS Dx (R1), Substantially Equivalent on 2026-04-10. Applicant: 3Shape TRIOS A/S.
Summary
TRIOS Dx (R1) is a dental intraoral scanner — product code SHQ covers intraoral impression scanners used in restorative and orthodontic workflows. 3Shape is a Danish incumbent in the space; the TRIOS line competes with iTero (Align) and Medit at the high end of the scanner market.
Dental panel, Traditional 510(k). The "Dx" naming shift suggests a diagnostic-capability claim being added to the existing TRIOS scanner platform — AI-assisted caries or crack detection being the typical addition. That kind of claim expansion often explains why an otherwise mature scanner platform files a new 510(k).
3Shape TRIOS A/S files from Copenhagen. Three-month review clock, short for a Traditional 510(k), possibly reflecting the strength of the predicate lineage within 3Shape's own portfolio.
Clearance details
- Applicant
- 3Shape TRIOS A/S
- Product code
- Code SHQ
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Copenhagen, DK
Data sourced from openFDA. This site is unofficial and independent of the FDA.