K222619 is an FDA 510(k) clearance for the Ensmile. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Ensmile Pvt, Ltd. (Johar Town, PK). The FDA issued a Cleared decision on March 16, 2023, 198 days after receiving the submission on August 30, 2022.
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 | K222619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2022 |
| Decision Date | March 16, 2023 |
| Days to Decision | 198 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. |