FDA 510(k) Applications for Medical Device Product Code "LFC"
(Device, Caries Detection)

FDA 510(k) Number Applicant Device Name Decision Date
K994368 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS 03/14/2000
K963927 CENTRIX, INC. TEAM CARIES INDICATOR 11/15/1996
K030807 CONFI-DENTAL PRODUCTS CO. CARIES INDICATOR 06/09/2003
K955445 DANVILLE ENGINEERING, INC. CARIES FINDER 02/08/1996
K200601 GreenMark Biomedical Inc. LumiCare Caries Diagnostic Rinse 03/29/2021
K222560 Incisive Technologies Pty Ltd BlueCheckÖ Caries Detection & Monitoring 05/16/2023
K193447 Inter-Med / Vista Dental Products Vista Dyes 03/11/2020
K012733 KURARAY MEDICAL INC. CARIES DETECTOR 09/14/2001
K973200 PARKELL, INC. CARIES STAIN 11/06/1997
K982105 PERTEC OF WISCONSIN, INC. ORAL POTENTIAL METER (OPM) 09/16/1998
K102821 PHOENIX DENTAL, INC. DISCOVRED 03/11/2011
K964430 PULPDENT CORP. PULPDENT SNOOP 01/17/1997
K060330 RONVIG DENTAL MFG. A/S SEE-IT CARIES DETECTOR 04/07/2006


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