Product Code: LFC FDA class 2 21 CFR 872.1740

Device, Caries Detection

Dental

A caries detection device is a dental instrument used to identify and locate dental caries (tooth decay) by detecting changes in tooth structure that indicate the presence of cavities, aiding clinicians in early diagnosis and treatment planning. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFC and is regulated under 21 CFR 872.1740 within the Dental specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: LFC
Device Class: FDA class 2
Regulation Number: 872.1740
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222560	BlueCheck Caries Detection & Monitoring	May 16, 2023	Substantially Equivalent	Incisive Technologies Pty, Ltd.
K200601	LumiCare Caries Diagnostic Rinse	Mar 29, 2021	Substantially Equivalent	GreenMark Biomedical, Inc.
K193447	Vista Dyes	Mar 11, 2020	Substantially Equivalent	Inter-Med/Vista Dental Products
K102821	DISCOVRED	Mar 11, 2011	Substantially Equivalent	Phoenix Dental, Inc.
K060330	SEE-IT CARIES DETECTOR	Apr 07, 2006	Substantially Equivalent	Ronvig Dental Mfg. A/S
K030807	CARIES INDICATOR	Jun 09, 2003	Substantially Equivalent	Confi-Dental Products Co.
K012733	CARIES DETECTOR	Sep 14, 2001	Substantially Equivalent	Kuraray Medical, Inc.
K994368	AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS	Mar 14, 2000	Substantially Equivalent	American Dental Products, Inc.
K982105	ORAL POTENTIAL METER (OPM)	Sep 16, 1998	Substantially Equivalent	Pertec of Wisconsin, Inc.
K973200	CARIES STAIN	Nov 06, 1997	Substantially Equivalent	Parkell, Inc.
K964430	PULPDENT SNOOP	Jan 17, 1997	Substantially Equivalent	Pulpdent Corp.
K963927	TEAM CARIES INDICATOR	Nov 15, 1996	Substantially Equivalent	Centrix, Inc.
K955445	CARIES FINDER	Feb 08, 1996	Substantially Equivalent	Danville Engineering, Inc.
K953526	SEEK	Sep 05, 1995	Substantially Equivalent	Ultradent Products, Inc.
K951813	CARIES DETECTOR	Jul 11, 1995	Substantially Equivalent	Kuraray Co.
K913405	KAR-D-TEK	Oct 28, 1991	Substantially Equivalent	Gresco Products, Inc.
K791133	ABCOR CARIES DETECTOR MONITOR	Aug 28, 1979	Substantially Equivalent	Abcor, Inc.