Dental
TRIOS Dx (R1)
3Shape TRIOS A/S
FDA
FDA-cleared AI medical device
A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions.
FDA Submission Metadata
- Submission number
- K260082
- Decision date
- April 2026
- FDA panel
- Dental
- Product code
- SHQ
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K260082
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.