K200908 is an FDA 510(k) clearance for the iSMILE. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by 3D Diagnostix, Inc. (Allston, US). The FDA issued a Cleared decision on December 22, 2020, 260 days after receiving the submission on April 6, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K200908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |