K233865
- 510(k) number
- K233865
- Device name
- X-Smart Pro; X-Smart Pro+
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2024-07-24
- Date received
- 2023-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K233865.pdf
Official FDA record: K233865
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.