TRIOS Ready Tip
K-Number: K242103 · 2025-04-04
Applicant3Shape TRIOS A/S
Decision Date2025-04-04
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TRIOS Ready Tip is a medical device manufactured by 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2025-04-04 under approval number K242103. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRIOS Ready Tip?
TRIOS Ready Tip is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by 3Shape TRIOS A/S. The 510(k) number is K242103.
When was TRIOS Ready Tip approved by the FDA?
TRIOS Ready Tip received FDA 510(k) clearance on 2025-04-04, under approval number K242103.
What company makes TRIOS Ready Tip?
TRIOS Ready Tip is manufactured by 3Shape TRIOS A/S.
What is the FDA product code for TRIOS Ready Tip?
The FDA product code for TRIOS Ready Tip is NBL.
Other Devices by 3Shape TRIOS A/S
Related Devices (Code: NBL)
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.