510(k) K251454
K251454 is an FDA 510(k) premarket notification submitted by Beame Medical Technology (Shenzhen) Limited for the device "Clear Aligner (SCF-3348)". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- May 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aligner, Sequential
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.