K260722
- 510(k) number
- K260722
- Device name
- SureSmile Aligner (ASSY500020)
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2026-04-15
- Date received
- 2026-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260722.pdf
Official FDA record: K260722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.