K251454
- 510(k) number
- K251454
- Device name
- Clear Aligner (SCF-3348)
- Applicant
- Beame Medical Technology (Shenzhen) Limited CN
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2026-01-07
- Date received
- 2025-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251454.pdf
Official FDA record: K251454
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.