K242637 is an FDA 510(k) clearance for the MEM Clear Aligner System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Mem Dental Technology Co., Ltd. (Tainan City, TW). The FDA issued a Cleared decision on May 21, 2025, 260 days after receiving the submission on September 3, 2024.
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 | K242637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | May 21, 2025 |
| Days to Decision | 260 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. |