K260082
- 510(k) number
- K260082
- Device name
- TRIOS Dx (R1)
- Applicant
- 3Shape TRIOS A/S DK
- Product code
- SHQ — Dental Image Analyzer, In-Office
- Decision date
- 2026-04-10
- Date received
- 2026-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260082.pdf
Official FDA record: K260082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.