Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LFC — Predicate Candidate Screening

17 FDA 510(k) clearances under this product code; the 50 most recent screened below.

78 daysmedian FDA review time

265 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K222560	BlueCheck™ Caries Detection & Monitoring	Incisive Technologies Pty, Ltd.	2023-05-16	265
K200601	LumiCare Caries Diagnostic Rinse	GreenMark Biomedical, Inc.	2021-03-29	385
K193447	Vista Dyes	Inter-Med/Vista Dental Products	2020-03-11	89
K102821	DISCOVRED	Phoenix Dental, Inc.	2011-03-11	164
K060330	SEE-IT CARIES DETECTOR	Ronvig Dental Mfg. A/S	2006-04-07	57
K030807	CARIES INDICATOR	Confi-Dental Products Co.	2003-06-09	88
K012733	CARIES DETECTOR	Kuraray Medical, Inc.	2001-09-14	31
K994368	AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS	American Dental Products, Inc.	2000-03-14	78
K982105	ORAL POTENTIAL METER (OPM)	Pertec of Wisconsin, Inc.	1998-09-16	92
K973200	CARIES STAIN	Parkell, Inc.	1997-11-06	72
K964430	PULPDENT SNOOP	Pulpdent Corp.	1997-01-17	73
K963927	TEAM CARIES INDICATOR	Centrix, Inc.	1996-11-15	66
K955445	CARIES FINDER	Danville Engineering, Inc.	1996-02-08	71
K953526	SEEK	Ultradent Products, Inc.	1995-09-05	40
K951813	CARIES DETECTOR	Kuraray Co.	1995-07-11	84
K913405	KAR-D-TEK	Gresco Products, Inc.	1991-10-28	90
K791133	ABCOR CARIES DETECTOR MONITOR	Abcor, Inc.	1979-08-28	71

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda