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) from 3Shape TRIOS is filed under SHQ, in-office dental image analyzers. The code covers prescription software that collects and analyzes optical camera-based intraoral images to aid dental professionals in diagnosing oral health conditions. The record doesn't say what "R1" means.
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).
Clearance details
- Applicant
- 3Shape TRIOS A/S
- Product code
- Product 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
view allData sourced from openFDA. This site is unofficial and independent of the FDA.