510(k) K260082
K260082 is an FDA 510(k) premarket notification submitted by 3Shape TRIOS A/S for the device "TRIOS Dx (R1)". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code SHQ (Dental Image Analyzer, In-Office), a Class II device regulated under 21 CFR 872.1770. 3Shape TRIOS A/S has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- January 12, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Image Analyzer, In-Office
- Device Class
- Class II
- Regulation Number
- 872.1770
- Review Panel
- DE
- Submission Type
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.