K253365
- 510(k) number
- K253365
- Device name
- LuxCreo Flexible Partial Denture Resin
- Applicant
- LuxCreo, Inc. IL · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2025-11-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253365.pdf
Official FDA record: K253365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.