Cleared Traditional

K222560 - BlueCheck Caries Detection & Monitoring

K222560 is an FDA 510(k) clearance for BlueCheck Caries Detection & Monitoring, manufactured by Incisive Technologies Pty, Ltd.. The device is a Class 2 Dental device with product code LFC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K222560 · Incisive Technologies Pty, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
265d
Days
Class 2
Risk

K222560 is an FDA 510(k) clearance for the BlueCheck™ Caries Detection & Monitoring. Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Incisive Technologies Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on May 16, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1740 - 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. Standard predicate reliance. 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 Incisive Technologies Pty, Ltd. devices

FDA 510(k) Submission Details - K222560

510(k) Number K222560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 127d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFC Device Classification - Class 2, Special Controls

Product Code LFC Device, Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1740
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 Consultant

PaxMed International, LLC
Melissa Burbage

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFC Device, Caries Detection

All 10
Devices cleared under the same product code (LFC) and FDA review panel - the closest regulatory comparables to K222560.
LumiCare Caries Diagnostic Rinse
K200601 · GreenMark Biomedical, Inc. · Mar 2021
Vista Dyes
K193447 · Inter-Med/Vista Dental Products · Mar 2020
CARIES INDICATOR
K030807 · Confi-Dental Products Co. · Jun 2003
CARIES DETECTOR
K012733 · Kuraray Medical, Inc. · Sep 2001
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
K994368 · American Dental Products, Inc. · Mar 2000
CARIES STAIN
K973200 · Parkell, Inc. · Nov 1997