FDA · official record K242103Substantially Equivalent

TRIOS Ready Tip

Name: TRIOS Ready Tip — FDA K242103
Creator: 3Shape TRIOS A/S
Keywords: TRIOS Ready Tip, TRIOS Ready Tip, K242103, NBL, FDA

United StatesNBL3Shape TRIOS A/S

Verified

Official record identity

FDA application number: K242103
Decision date: April 04, 2025
Published decision: Substantially Equivalent

Classification

Product code: NBL

Published parties

Applicant: 3Shape TRIOS A/S

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2024-07-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1745

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.