Cleared Traditional

BlueCheck? Caries Detection & Monitoring

K222560 · Incisive Technologies Pty, Ltd. · Dental
May 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K222560 is an FDA 510(k) clearance for the BlueCheck? Caries Detection & Monitoring, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Incisive Technologies Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on May 16, 2023, 265 days after receiving the submission on August 24, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K222560 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2022
Decision Date May 16, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFC — Device, Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1740