510(k) K251758
K251758 is an FDA 510(k) premarket notification submitted by Tns Co., Ltd. for the device "Serafin®". The FDA issued a decision of Substantially Equivalent on September 11, 2025. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Tns Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2025
- Date Received
- June 9, 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.