TRIOS Dx (R1)
K-Number: K260082 · 2026-04-10
Applicant3Shape TRIOS A/S
Decision Date2026-04-10
Product CodeSHQ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TRIOS Dx (R1) is a medical device manufactured by 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2026-04-10 under approval number K260082. The device is classified under product code SHQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRIOS Dx (R1)?
TRIOS Dx (R1) is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by 3Shape TRIOS A/S. The 510(k) number is K260082.
When was TRIOS Dx (R1) approved by the FDA?
TRIOS Dx (R1) received FDA 510(k) clearance on 2026-04-10, under approval number K260082.
What company makes TRIOS Dx (R1)?
TRIOS Dx (R1) is manufactured by 3Shape TRIOS A/S.
What is the FDA product code for TRIOS Dx (R1)?
The FDA product code for TRIOS Dx (R1) is SHQ.
Other Devices by 3Shape TRIOS A/S
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.