K192244 is an FDA 510(k) clearance for the Arcad SmileStudio and Aligner System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Arcadlab (West Palm Beach, US). The FDA issued a Cleared decision on May 11, 2020, 266 days after receiving the submission on August 19, 2019.
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 | K192244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2019 |
| Decision Date | May 11, 2020 |
| Days to Decision | 266 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. |