510(k) K222560
- Device
- BlueCheck? Caries Detection & Monitoring
- Applicant
- Incisive Technologies Pty, Ltd.
- 510(k) number
- K222560
- Product code
- LFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-16
- Date received
- 2022-08-24
- Regulation
- 872.1740
- Classification name
- Device, Caries Detection
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kerry A Hegarty
- Address
- Level 4, 71 Collins St. Melbourne AU 3000 3000
FDA Registration Numbers#
- 3032823828
- 3038718579
- 3012421607
- 3002807420
- 1718912
- 3033588343
- 2023950
- 1215305
- 2320721
- 1281412
- 3020856747
- 3011533696
- 3028011
- 2133714
Source Documents#
Other 510(k) Records For Product Code LFC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |