510(k) K260082
- Device
- TRIOS Dx (R1)
- Applicant
- 3Shape TRIOS A/S
- 510(k) number
- K260082
- Product code
- SHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-10
- Date received
- 2026-01-12
- Regulation
- 872.1770
- Classification name
- Dental Image Analyzer, In-Office
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jenny Axel
- Address
- Holmens Kanal 7 Copenhagen DK 1060 1060
FDA Registration Numbers
- 3009560013
- 3015172511