K193659 is an FDA 510(k) clearance for the iTero Element 5D. This device is classified as a Caries Detector, Laser Light, Transmission (Class II - Special Controls, product code NTK).
Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on March 20, 2020, 81 days after receiving the submission on December 30, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K193659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2019 |
| Decision Date | March 20, 2020 |
| Days to Decision | 81 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 |