TRIOS Dx (R1)
FDA 510(k) clearance K260082 · decided 2026-04-10
Clearance details
- K-number
- K260082
- Device name
- TRIOS Dx (R1)
- Applicant
- 3Shape TRIOS A/S
- Decision
- Substantially Equivalent
- Date received
- 2026-01-12
- Decision date
- 2026-04-10
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- SHQ
- Device class
- 2
- Regulation number
- 872.1770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Copenhagen, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.