Dental Device Guide
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Diagnostic devices · 21 CFR 872 Subpart B

Caries Detection Device

FDA device type “Device, Caries Detection”.

FDA codeLFCClass221 CFR872.1740Pathway510(k)CategoryCaries detection devices
Companies listing it
159 makers
Brands and models
10
510(k) clearances
171 in five years
FDA name
Device, Caries Detection
1979: 11991: 11995: 21996: 21997: 21998: 12000: 12001: 12003: 12006: 12011: 12020: 12021: 12023: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list LFC

15 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Zest Anchors, LLCUnited StatesMaker—262026
Ultradent Products, Inc.United StatesMakerSable Seek · Seek952026
Kuraray Noritake Dental, Inc.JapanMakerCARIES DETECTOR322025
Centrix, Inc.United StatesMakerExpose'442025
GreenMark Biomedical Inc.United StatesMakerLumiCare22025
Incisive Technologies Pty LtdAustraliaMakerBlueCheck12023
Pulpdent CorporationUnited StatesMakerSnoop Caries Detecting Dye1072021
Marturion Electronics LtdUnited KingdomMakerOrtek ECD——
Silgan UnicepUnited StatesMaker———
Dentsply Sirona, Inc.United StatesContract manufacturer—1482026
Inter-Med, Inc.United StatesContract manufacturerCaries Red and Green72026
Patterson Companies, Inc.United StatesForeign exporterCaries Indicator——
CBE Pure Solutions Pty LtdAustraliaRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
16 May 2023K222560BlueCheck™ Caries Detection & MonitoringIncisive Technologies Pty Ltd
29 Mar 2021K200601LumiCare Caries Diagnostic RinseGreenMark Biomedical Inc.
11 Mar 2020K193447Vista DyesInter-Med/Vista Dental Products
11 Mar 2011K102821DISCOVREDPhoenix Dental, Inc.
7 Apr 2006K060330SEE-IT CARIES DETECTORRonvig Dental Mfg. A/S
9 Jun 2003K030807CARIES INDICATORConfi-Dental Products Co.
14 Sep 2001K012733CARIES DETECTORKuraray Medical, Inc.
14 Mar 2000K994368AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUSAmerican Dental Products, Inc.
16 Sep 1998K982105ORAL POTENTIAL METER (OPM)Pertec of Wisconsin, Inc.
6 Nov 1997K973200CARIES STAINParkell, Inc
17 Jan 1997K964430PULPDENT SNOOPPulpdent Corporation
15 Nov 1996K963927TEAM CARIES INDICATORCentrix, Inc.
8 Feb 1996K955445CARIES FINDERDanville Engineering, Inc.
5 Sep 1995K953526SEEKUltradent Products, Inc.
11 Jul 1995K951813CARIES DETECTORKuraray Company, Ltd.
28 Oct 1991K913405KAR-D-TEKGresco Products, Inc.
28 Aug 1979K791133ABCOR CARIES DETECTOR MONITORAbcor, Inc.

Official records: FDA product classification for LFC · 21 CFR 872.1740.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026