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FDA 510(k)

L1P-1F (TRIOS 5)

K-Number: K221249 · 2022-09-16

Applicant3Shape TRIOS A/S
Decision Date2022-09-16
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

L1P-1F (TRIOS 5) is a medical device manufactured by 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2022-09-16 under approval number K221249. 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 L1P-1F (TRIOS 5)?

L1P-1F (TRIOS 5) is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by 3Shape TRIOS A/S. The 510(k) number is K221249.

When was L1P-1F (TRIOS 5) approved by the FDA?

L1P-1F (TRIOS 5) received FDA 510(k) clearance on 2022-09-16, under approval number K221249.

What company makes L1P-1F (TRIOS 5)?

L1P-1F (TRIOS 5) is manufactured by 3Shape TRIOS A/S.

What is the FDA product code for L1P-1F (TRIOS 5)?

The FDA product code for L1P-1F (TRIOS 5) is NBL.

Other Devices by 3Shape TRIOS A/S

K242103TRIOS Ready Tip K260082TRIOS Dx (R1)

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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.

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