K193385 is an FDA 510(k) clearance for the TP Orthodontics Clear Aligner System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on November 12, 2020, 342 days after receiving the submission on December 6, 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 | K193385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2019 |
| Decision Date | November 12, 2020 |
| Days to Decision | 342 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. |