Product code LFC
- Device name
- Device, Caries Detection
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1740
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222560 | BlueCheck⢠Caries Detection & Monitoring | Incisive Technologies Pty, Ltd. | 2023-05-16 |
| K200601 | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical, Inc. | 2021-03-29 |
| K193447 | Vista Dyes | Inter-Med/Vista Dental Products | 2020-03-11 |
| K102821 | DISCOVRED | Phoenix Dental, Inc. | 2011-03-11 |
| K060330 | SEE-IT CARIES DETECTOR | Ronvig Dental Mfg. A/S | 2006-04-07 |
| K030807 | CARIES INDICATOR | Confi-Dental Products Co. | 2003-06-09 |
| K012733 | CARIES DETECTOR | Kuraray Medical, Inc. | 2001-09-14 |
| K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | American Dental Products, Inc. | 2000-03-14 |
| K982105 | ORAL POTENTIAL METER (OPM) | Pertec of Wisconsin, Inc. | 1998-09-16 |
| K973200 | CARIES STAIN | Parkell, Inc. | 1997-11-06 |
| K964430 | PULPDENT SNOOP | Pulpdent Corp. | 1997-01-17 |
| K963927 | TEAM CARIES INDICATOR | Centrix, Inc. | 1996-11-15 |
| K955445 | CARIES FINDER | Danville Engineering, Inc. | 1996-02-08 |
| K953526 | SEEK | Ultradent Products, Inc. | 1995-09-05 |
| K951813 | CARIES DETECTOR | Kuraray Co. | 1995-07-11 |
| K913405 | KAR-D-TEK | Gresco Products, Inc. | 1991-10-28 |
| K791133 | ABCOR CARIES DETECTOR MONITOR | Abcor, Inc. | 1979-08-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09359621000021 | BlueCheck | INCISIVE TECHNOLOGIES PTY LTD | 2025-02-26 |
| 09359621000038 | BlueCheck | INCISIVE TECHNOLOGIES PTY LTD | 2024-11-20 |
| 09359621000014 | BlueCheck | INCISIVE TECHNOLOGIES PTY LTD | 2024-11-20 |
| 00817051021706 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051021690 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051021744 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051022338 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051022345 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051022352 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00817051022369 | Expose | CENTRIX, INC. | 2023-12-22 |
| 00858197004062 | Ortek Therapeutics, Inc. | ORTEK THERAPEUTICS, INC | 2022-12-21 |
| 10818207020854 | Vista Blue Unit Dose Kit | Vista Dental | 2021-01-29 |
| 00304040027820 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-24 |
| 00304040133422 | Henry Schein | HENRY SCHEIN, INC. | 2020-07-30 |
| 10818207020380 | Mixing Wells | Vista Dental | 2018-07-31 |
| 10818207020090 | Vista-Green Unit Dose | Vista Dental | 2018-07-31 |
| 10818207020083 | Vista-Green Caries Indicator Value Pack | Vista Dental | 2018-07-31 |
| 10818207020076 | Vista-Green Caries Indicator Refill Pack | Vista Dental | 2018-07-31 |
| 10818207020069 | Vista-Green Caries Indicator Standard Kit | Vista Dental | 2018-07-31 |
| 10818207020045 | Vista-Red Caries Unit Dose | Vista Dental | 2018-07-31 |
| 10818207020038 | Vista-Red Caries Value Pack | Vista Dental | 2018-07-31 |
| 10818207020021 | Vista-Red Caries Refill Pack | Vista Dental | 2018-07-31 |
| 10818207020014 | Vista-Red Caries Indicator Standard Pack | Vista Dental | 2018-07-31 |
| 10304040007089 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| D6620708425180 | PATTERSON | PATTERSON DENTAL SUPPLY, INC. | 2016-09-23 |
| D701SNOOP2 | SNOOP | PULPDENT CORPORATION | 2016-09-01 |
| D724C660394 | Pearson Caries Indicator Green syringe Kit | PEARSON DENTAL SUPPLIES, INC. | 2016-07-07 |
| D724C6603921 | Pearson Caries Indicator Green Bottle | PEARSON DENTAL SUPPLIES, INC. | 2016-07-07 |
| D724C6603911 | Pearson Caries Indicator Red Bottle | PEARSON DENTAL SUPPLIES, INC. | 2016-07-07 |
| 00889813000915 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2016-06-21 |