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510(k) K222560

BlueCheck™ Caries Detection & Monitoring by Incisive Technologies Pty, Ltd. — Product Code LFC

K222560 is an FDA 510(k) premarket notification submitted by Incisive Technologies Pty, Ltd. for the device "BlueCheck™ Caries Detection & Monitoring". The FDA issued a decision of Substantially Equivalent on May 16, 2023. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2023
Date Received
August 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Caries Detection
Device Class
Class II
Regulation Number
872.1740
Review Panel
DE
Submission Type

Other clearances for product code LFC

  • K200601 — LumiCare Caries Diagnostic Rinse (March 29, 2021)
  • K193447 — Vista Dyes (March 11, 2020)
  • K102821 — DISCOVRED (March 11, 2011)
  • K060330 — SEE-IT CARIES DETECTOR (April 7, 2006)
  • K030807 — CARIES INDICATOR (June 9, 2003)
  • K012733 — CARIES DETECTOR (September 14, 2001)
  • K994368 — AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (March 14, 2000)
  • K982105 — ORAL POTENTIAL METER (OPM) (September 16, 1998)
  • K973200 — CARIES STAIN (November 6, 1997)
  • K964430 — PULPDENT SNOOP (January 17, 1997)

FDA data resources