K192596 is an FDA 510(k) clearance for the ULab Systems Dental Aligner Kit. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Ulab Systems, Inc. (Redwood City, US). The FDA issued a Cleared decision on February 11, 2020, 144 days after receiving the submission on September 20, 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 | K192596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | February 11, 2020 |
| Days to Decision | 144 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. |