LFC
17 FDA 510(k) clearances · Product code
78 daysmedian time to decision
265 days90th percentile
17clearances measured
FDA profile
- Official device name
- Device, Caries Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.1740
- Medical specialty
- Dental
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BlueCheck™ Caries Detection & Monitoring (K222560) | Incisive Technologies Pty, Ltd. | 2023-05-16 |
| LumiCare Caries Diagnostic Rinse (K200601) | GreenMark Biomedical, Inc. | 2021-03-29 |
| Vista Dyes (K193447) | Inter-Med/Vista Dental Products | 2020-03-11 |
| DISCOVRED (K102821) | Phoenix Dental, Inc. | 2011-03-11 |
| SEE-IT CARIES DETECTOR (K060330) | Ronvig Dental Mfg. A/S | 2006-04-07 |
| CARIES INDICATOR (K030807) | Confi-Dental Products Co. | 2003-06-09 |
| CARIES DETECTOR (K012733) | Kuraray Medical, Inc. | 2001-09-14 |
| AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (K994368) | American Dental Products, Inc. | 2000-03-14 |
| ORAL POTENTIAL METER (OPM) (K982105) | Pertec of Wisconsin, Inc. | 1998-09-16 |
| CARIES STAIN (K973200) | Parkell, Inc. | 1997-11-06 |
| PULPDENT SNOOP (K964430) | Pulpdent Corp. | 1997-01-17 |
| TEAM CARIES INDICATOR (K963927) | Centrix, Inc. | 1996-11-15 |
| CARIES FINDER (K955445) | Danville Engineering, Inc. | 1996-02-08 |
| SEEK (K953526) | Ultradent Products, Inc. | 1995-09-05 |
| CARIES DETECTOR (K951813) | Kuraray Co. | 1995-07-11 |
| KAR-D-TEK (K913405) | Gresco Products, Inc. | 1991-10-28 |
| ABCOR CARIES DETECTOR MONITOR (K791133) | Abcor, Inc. | 1979-08-28 |
Track LFC automatically
Every clearance here is in the API, with alerts when new ones post.