K242103 is an FDA 510(k) clearance for the TRIOS Ready Tip. This device is classified as a Laser, Fluorescence Caries Detection (Class II - Special Controls, product code NBL).
Submitted by 3Shape TRIOS A/S (Copenhagen, DK). The FDA issued a Cleared decision on April 4, 2025, 260 days after receiving the submission on July 18, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K242103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NBL - Laser, Fluorescence Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |