510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222560Substantially Equivalent

BlueCheck™ Caries Detection & Monitoring

Incisive Technologies Pty Ltd, Melbourne, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222560 is the FDA 510(k) clearance record for BlueCheck™ Caries Detection & Monitoring, a class II device, cleared for Incisive Technologies Pty, Ltd. on under FDA product code LFC (Device, Caries Detection). FDA records list 4 510(k) clearances for Incisive Technologies Pty, Ltd., from to . As of , FDA records show no recalls naming K222560.

Clearance record

Decision date
Received
(265 days to decision)
Product code
LFC Device, Caries Detection
Regulation
21 CFR 872.1740
Device class
Class II
Review panel
Dental
Applicant
Incisive Technologies Pty, Ltd. Level 4, 71 Collins St., Melbourne, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFC

Trailing 12 months

FDA records hold no clearances under product code LFC in the trailing twelve months.

FDA records show no clearances under product code LFC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260