K252931
- 510(k) number
- K252931
- Device name
- Invisalign® Palatal Expander System
- Applicant
- Align Technology, Inc. CA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-10-23
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252931.pdf
Official FDA record: K252931
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.