Device, Caries Detection
Regulation 872.1740
0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LFC
| Company | 510(k)s | Recalls |
|---|---|---|
| Abcor, Inc. | 1 | 0 |
| American Dental Products, Inc. | 1 | 0 |
| Centrix, Inc. | 1 | 0 |
| Confi-Dental Products Co. | 1 | 0 |
| Danville Engineering, Inc. | 1 | 0 |
| GreenMark Biomedical, Inc. | 1 | 0 |
| Gresco Products, Inc. | 1 | 0 |
| Incisive Technologies Pty, Ltd. | 1 | 0 |
| Inter-Med/Vista Dental Products | 1 | 0 |
| Kuraray Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2023 | K222560 | BlueCheck Caries Detection & Monitoring Incisive Technologies Pty, Ltd., AU | LFC |
| Mar 29, 2021 | K200601 | LumiCare Caries Diagnostic Rinse GreenMark Biomedical, Inc. | LFC |
| Mar 11, 2020 | K193447 | Vista Dyes Inter-Med/Vista Dental Products | LFC |
| Mar 11, 2011 | K102821 | DISCOVRED Phoenix Dental, Inc. | LFC |
| Apr 7, 2006 | K060330 | SEE-IT CARIES DETECTOR Ronvig Dental Mfg. A/S, DK | LFC |
| Jun 9, 2003 | K030807 | CARIES INDICATOR Confi-Dental Products Co. | LFC |
| Sep 14, 2001 | K012733 | CARIES DETECTOR Kuraray Medical, Inc. | LFC |
| Mar 14, 2000 | K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS American Dental Products, Inc. | LFC |
| Sep 16, 1998 | K982105 | ORAL POTENTIAL METER (OPM) Pertec of Wisconsin, Inc. | LFC |
| Nov 6, 1997 | K973200 | CARIES STAIN Parkell, Inc. | LFC |
| Jan 17, 1997 | K964430 | PULPDENT SNOOP Pulpdent Corp. | LFC |
| Nov 15, 1996 | K963927 | TEAM CARIES INDICATOR Centrix, Inc. | LFC |
| Feb 8, 1996 | K955445 | CARIES FINDER Danville Engineering, Inc. | LFC |
| Sep 5, 1995 | K953526 | SEEK Ultradent Products, Inc. | LFC |
| Jul 11, 1995 | K951813 | CARIES DETECTOR Kuraray Co. | LFC |
| Oct 28, 1991 | K913405 | KAR-D-TEK Gresco Products, Inc. | LFC |
| Aug 28, 1979 | K791133 | ABCOR CARIES DETECTOR MONITOR Abcor, Inc. | LFC |
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