Cleared Traditional

SmarTooth

K231722 · Smartooth Co., Ltd. · Dental
May 2024
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K231722 is an FDA 510(k) clearance for the SmarTooth, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Smartooth Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 1, 2024, 323 days after receiving the submission on June 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K231722 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2023
Decision Date May 01, 2024
Days to Decision 323 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