K251454 is an FDA 510(k) clearance for the Clear Aligner (SCF-3348). This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Beame Medical Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2026, 240 days after receiving the submission on May 12, 2025.
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 | K251454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2025 |
| Decision Date | January 07, 2026 |
| Days to Decision | 240 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. |