Cleared Traditional

TRIOS Ready Tip

K242103 · 3Shape TRIOS A/S · Dental

Apr 2025

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K242103 is an FDA 510(k) clearance for the TRIOS Ready Tip, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by 3Shape TRIOS A/S (Copenhagen, DK). The FDA issued a Cleared decision on April 4, 2025, 260 days after receiving the submission on July 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number	K242103 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2024
Decision Date	April 04, 2025
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF