Device, Caries Detection
FDA product code LFC · Class II (moderate risk) · 21 CFR 872.1740 · Dental
17510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Pertec of Wisconsin, Inc. 1
- Incisive Technologies, Inc. 1
- GreenMark Biomedical, Inc. 1
- Inter-Med/Vista Dental Products 1
- Phoenix Dental, Inc. 1
- Ronvig Dental Mfg. A/S 1
- Confi-Dental Products Co. 1
- Kuraray Medical, Inc. 1
- American Dental Products, Inc. 1
- Abcor, Inc. 1
- Parkell, Inc. 1
- Pulpdent Corp. 1
- Centrix, Inc. 1
- Danville Engineering, Inc. 1
- Ultradent Products, Inc. 1
- Kuraray Co. 1
- Gresco Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222560 | BlueCheck Caries Detection & MonitoringLFC · Traditional | Incisive Technologies Pty, Ltd. | 05/16/2023SE |
| K200601 | LumiCare Caries Diagnostic RinseLFC · Traditional | GreenMark Biomedical, Inc. | 03/29/2021SE |
| K193447 | Vista DyesLFC · Traditional | Inter-Med/Vista Dental Products | 03/11/2020SE |
| K102821 | DiscovredLFC · Traditional | Phoenix Dental, Inc. | 03/11/2011SE |
| K060330 | See-It Caries DetectorLFC · Traditional | Ronvig Dental Mfg. A/S | 04/07/2006SE |
| K030807 | Caries IndicatorLFC · Traditional | Confi-Dental Products Co. | 06/09/2003SE |
| K012733 | Caries DetectorLFC · Traditional | Kuraray Medical, Inc. | 09/14/2001SE |
| K994368 | American Dental Products Caries-Detector PlusLFC · Traditional | American Dental Products, Inc. | 03/14/2000SE |
| K982105 | Oral Potential Meter (Opm)LFC · Traditional | Pertec of Wisconsin, Inc. | 09/16/1998SE |
| K973200 | Caries StainLFC · Traditional | Parkell, Inc. | 11/06/1997SE |
| K964430 | Pulpdent SnoopLFC · Traditional | Pulpdent Corp. | 01/17/1997SE |
| K963927 | Team Caries IndicatorLFC · Traditional | Centrix, Inc. | 11/15/1996SE |
| K955445 | Caries FinderLFC · Traditional | Danville Engineering, Inc. | 02/08/1996SE |
| K953526 | SeekLFC · Traditional | Ultradent Products, Inc. | 09/05/1995SE |
| K951813 | Caries DetectorLFC · Traditional | Kuraray Co. | 07/11/1995SE |
| K913405 | Kar-D-TekLFC · Traditional | Gresco Products, Inc. | 10/28/1991SE |
| K791133 | Abcor Caries Detector MonitorLFC · Traditional | Abcor, Inc. | 08/28/1979SE |