Cleared Traditional

K223470 - C50

K223470 is an FDA 510(k) clearance for C50, manufactured by Sopro. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K223470 · Sopro · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
392d
Days
Class 2
Risk

K223470 is an FDA 510(k) clearance for the C50. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Sopro (La Ciotat, FR). The FDA issued a Cleared decision on December 14, 2023 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sopro devices

FDA 510(k) Submission Details - K223470

510(k) Number K223470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 127d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBL Device Classification - Class 2, Special Controls

Product Code NBL Laser, Fluorescence Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NBL Laser, Fluorescence Caries Detection

All 8
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K223470.
TRIOS Ready Tip
K242103 · 3Shape TRIOS A/S · Apr 2025
Qraycam PRO
K221275 · AIOBIO Co., Ltd. · Sep 2024
SmarTooth
K231722 · Smartooth Co., Ltd. · May 2024
L1P-1F (TRIOS 5)
K221249 · 3Shape TRIOS A/S · Sep 2022
IC-WHCD100 (Inspire)
K183471 · Good Doctors Co., Ltd. · Jul 2020
Fluorescence Mode
K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018