K190394 is an FDA 510(k) clearance for the SunClear Aligner system. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Sun Dental Laboratories, LLC (St. Petersburg, US). The FDA issued a Cleared decision on December 16, 2019, 300 days after receiving the submission on February 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 | K190394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | December 16, 2019 |
| Days to Decision | 300 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. |