K253282
- 510(k) number
- K253282
- Device name
- ZSmile System
- Applicant
- Dror Orthodesign , Ltd. IL
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2026-02-03
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253282.pdf
Official FDA record: K253282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.