K250343
- 510(k) number
- K250343
- Device name
- LuxCreo Clear Aligner System
- Applicant
- LuxCreo, Inc. IL · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-04-08
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250343.pdf
Official FDA record: K250343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.