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. Device class: 2.
Summary
TRIOS Dx (R1) is filed under SHQ, in-office dental image analyzers. 3Shape's TRIOS is an intraoral scanner line, and the "Dx" name and the product code point to diagnostic analysis of scan data rather than the scanner itself.
Class II, 21 CFR 872.1770. The Dental panel reviewed it as a Traditional 510(k).
3Shape TRIOS A/S filed from Copenhagen, Denmark. Review took 88 days (January 12 to April 10, 2026). That's inside FDA's 90-day goal even counted on the calendar, which doesn't happen often.
Clearance details
- Applicant
- 3Shape TRIOS A/S
- Product code
- Code SHQ
- Device class
- Class 2
- Regulation
- 21 CFR 872.1770
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Copenhagen, DK
More clearances from 3Shape TRIOS A/S
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