K251758
- 510(k) number
- K251758
- Device name
- Serafin®
- Applicant
- Tns Co., Ltd. KR
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-09-11
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251758.pdf
Official FDA record: K251758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.