K232564
- 510(k) number
- K232564
- Device name
- Align Studio
- Applicant
- Laon Medi, Inc. KR
- Product code
- PNN — Orthodontic Software
- Decision date
- 2024-03-12
- Date received
- 2023-08-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232564.pdf
Official FDA record: K232564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.