Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1740](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1740) → LFC — Device, Caries Detection

# LFC · Device, Caries Detection

_Dental · 21 CFR 872.1740 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC

## Overview

- **Product Code:** LFC
- **Device Name:** Device, Caries Detection
- **Regulation:** [21 CFR 872.1740](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1740)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K222560](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K222560.md) | BlueCheck™ Caries Detection & Monitoring | Incisive Technologies Pty, Ltd. | May 16, 2023 | SESE |
| [K200601](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K200601.md) | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical, Inc. | Mar 29, 2021 | SESE |
| [K193447](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K193447.md) | Vista Dyes | Inter-Med/Vista Dental Products | Mar 11, 2020 | SESE |
| [K102821](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K102821.md) | DISCOVRED | Phoenix Dental, Inc. | Mar 11, 2011 | SESE |
| [K060330](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K060330.md) | SEE-IT CARIES DETECTOR | Ronvig Dental Mfg. A/S | Apr 7, 2006 | SESE |
| [K030807](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K030807.md) | CARIES INDICATOR | Confi-Dental Products Co. | Jun 9, 2003 | SESE |
| [K012733](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K012733.md) | CARIES DETECTOR | Kuraray Medical, Inc. | Sep 14, 2001 | SESE |
| [K994368](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K994368.md) | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | American Dental Products, Inc. | Mar 14, 2000 | SESE |
| [K982105](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K982105.md) | ORAL POTENTIAL METER (OPM) | Pertec of Wisconsin, Inc. | Sep 16, 1998 | SESE |
| [K973200](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K973200.md) | CARIES STAIN | Parkell, Inc. | Nov 6, 1997 | SESE |
| [K964430](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K964430.md) | PULPDENT SNOOP | Pulpdent Corp. | Jan 17, 1997 | SESE |
| [K963927](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K963927.md) | TEAM CARIES INDICATOR | Centrix, Inc. | Nov 15, 1996 | SESE |
| [K955445](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K955445.md) | CARIES FINDER | Danville Engineering, Inc. | Feb 8, 1996 | SESE |
| [K953526](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K953526.md) | SEEK | Ultradent Products, Inc. | Sep 5, 1995 | SESE |
| [K951813](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K951813.md) | CARIES DETECTOR | Kuraray Co. | Jul 11, 1995 | SESE |
| [K913405](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K913405.md) | KAR-D-TEK | Gresco Products, Inc. | Oct 28, 1991 | SESE |
| [K791133](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC/K791133.md) | ABCOR CARIES DETECTOR MONITOR | Abcor, Inc. | Aug 28, 1979 | SESE |

## Top Applicants

- Abcor, Inc. — 1 clearance
- American Dental Products, Inc. — 1 clearance
- Centrix, Inc. — 1 clearance
- Confi-Dental Products Co. — 1 clearance
- Danville Engineering, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/LFC)

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