K232653
- 510(k) number
- K232653
- Device name
- Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
- Applicant
- Blue Sky Bio, LLC IL · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-04-03
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232653.pdf
Official FDA record: K232653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.