K240501
- 510(k) number
- K240501
- Device name
- Spark Clear Aligner System
- Applicant
- Ormco Corporation CA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-10-11
- Date received
- 2024-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K240501.pdf
Official FDA record: K240501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.