K213482 is an FDA 510(k) clearance for the TIA Tip, Cariosity, Transillumination Accessory Tip. This device is classified as a Caries Detector, Laser Light, Transmission (Class II - Special Controls, product code NTK).
Submitted by D4D Technologies, LLC (Richardson, US). The FDA issued a Cleared decision on April 29, 2022, 182 days after receiving the submission on October 29, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K213482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NTK - Caries Detector, Laser Light, Transmission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |