K231884 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 Modern Dental Laboratory (Dg) Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on September 1, 2023, 66 days after receiving the submission on June 27, 2023.
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 | K231884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2023 |
| Decision Date | September 01, 2023 |
| Days to Decision | 66 days |
| Submission Type | Special |
| 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. |