Cleared Traditional

C50

K223470 · Sopro · Dental
Dec 2023
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K223470 is an FDA 510(k) clearance for the C50, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Sopro (La Ciotat, FR). The FDA issued a Cleared decision on December 14, 2023, 392 days after receiving the submission on November 17, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K223470 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2022
Decision Date December 14, 2023
Days to Decision 392 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