Clearance Summary
TRIOS Dx (R1) received FDA 510(k) clearance under submission number K260082, sponsored by 3Shape TRIOS A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-04-10.
- Submission: K260082
- Applicant / Sponsor: 3Shape TRIOS A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1770
- Decision date: 2026-04-10
Classification & Regulation
This clearance is catalogued under FDA product code SHQ and 21 CFR 872.1770, within the Dental review panel as a Class II device.