K200214 is an FDA 510(k) clearance for the 3D Predict. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by 3D Smile USA, Inc. (Philadelphia, US). The FDA issued a Cleared decision on February 24, 2020, 27 days after receiving the submission on January 28, 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 | K200214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2020 |
| Decision Date | February 24, 2020 |
| Days to Decision | 27 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. |