K253565
- 510(k) number
- K253565
- Device name
- SureSmile Software
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- PNN — Orthodontic Software
- Decision date
- 2026-03-04
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253565.pdf
Official FDA record: K253565
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.