K250487
- 510(k) number
- K250487
- Device name
- SparkTM Clear Aligner System
- Applicant
- Ormco Corporation CA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-02-20
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250487.pdf
Official FDA record: K250487
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.