K222560 is an FDA 510(k) clearance for the BlueCheck™ Caries Detection & Monitoring. This device is classified as a Device, Caries Detection (Class II - Special Controls, product code LFC).
Submitted by Incisive Technologies Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on May 16, 2023, 265 days after receiving the submission on August 24, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1740.
| 510(k) Number | K222560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2022 |
| Decision Date | May 16, 2023 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFC - Device, Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1740 |