K242929
- 510(k) number
- K242929
- Device name
- Fas Aligner System
- Applicant
- Xplora 3D Europe S.L ES
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-12-20
- Date received
- 2024-09-24
- 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: K242929.pdf
Official FDA record: K242929
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.