FDA 510(k)

TRIOS Ready Tip

K-Number: K242103 · 2025-04-04

Decision Date2025-04-04

Product CodeNBL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TRIOS Ready Tip is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2025-04-04 under 510(k) 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. The listed applicant is 3Shape TRIOS A/S. The 510(k) number is K242103.

When did TRIOS Ready Tip receive FDA 510(k) clearance?

TRIOS Ready Tip received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242103.

Who is the listed applicant for TRIOS Ready Tip?

The FDA 510(k) record lists 3Shape TRIOS A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOS Ready Tip?

The FDA product code for TRIOS Ready Tip is NBL.

Other records listing 3Shape TRIOS A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260082TRIOS Dx (R1)K221249L1P-1F (TRIOS 5)

Related Devices (Code: NBL)

K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.K221275Qraycam PROAIOBIO Co., Ltd.K231722SmarToothSmartooth Co., Ltd.K223470C50Sopro K221249L1P-1F (TRIOS 5)3Shape TRIOS A/S K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.