K193622 is an FDA 510(k) clearance for the TRIOCLEAR System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Perfection Aligner System Hong Kong Limited (Kowloon, Hongkong, HK). The FDA issued a Cleared decision on July 6, 2021, 558 days after receiving the submission on December 26, 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 | K193622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2019 |
| Decision Date | July 06, 2021 |
| Days to Decision | 558 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. |