Cleared Traditional

L1P-1F (TRIOS 5)

K221249 · 3Shape TRIOS A/S · Dental
Sep 2022
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K221249 is an FDA 510(k) clearance for the L1P-1F (TRIOS 5), 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 September 16, 2022, 137 days after receiving the submission on May 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K221249 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2022
Decision Date September 16, 2022
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NBL — Laser, Fluorescence Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745