LFC · Device, Caries Detection
Dental · 21 CFR 872.1740 · Class 2
Overview
| Product Code | LFC |
|---|---|
| Device Name | Device, Caries Detection |
| Regulation | 21 CFR 872.1740 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | BlueCheck Caries Detection & Monitoring | Incisive Technologies Pty, Ltd. | May 16, 2023 | SESE |
| K200601 | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical, Inc. | Mar 29, 2021 | SESE |
| K193447 | Vista Dyes | Inter-Med/Vista Dental Products | Mar 11, 2020 | SESE |
| K102821 | DISCOVRED | Phoenix Dental, Inc. | Mar 11, 2011 | SESE |
| K060330 | SEE-IT CARIES DETECTOR | Ronvig Dental Mfg. A/S | Apr 7, 2006 | SESE |
| K030807 | CARIES INDICATOR | Confi-Dental Products Co. | Jun 9, 2003 | SESE |
| K012733 | CARIES DETECTOR | Kuraray Medical, Inc. | Sep 14, 2001 | SESE |
| K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | American Dental Products, Inc. | Mar 14, 2000 | SESE |
| K982105 | ORAL POTENTIAL METER (OPM) | Pertec of Wisconsin, Inc. | Sep 16, 1998 | SESE |
| K973200 | CARIES STAIN | Parkell, Inc. | Nov 6, 1997 | SESE |
| K964430 | PULPDENT SNOOP | Pulpdent Corp. | Jan 17, 1997 | SESE |
| K963927 | TEAM CARIES INDICATOR | Centrix, Inc. | Nov 15, 1996 | SESE |
| K955445 | CARIES FINDER | Danville Engineering, Inc. | Feb 8, 1996 | SESE |
| K953526 | SEEK | Ultradent Products, Inc. | Sep 5, 1995 | SESE |
| K951813 | CARIES DETECTOR | Kuraray Co. | Jul 11, 1995 | SESE |
| K913405 | KAR-D-TEK | Gresco Products, Inc. | Oct 28, 1991 | SESE |
| K791133 | 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
