X-Smart Pro; X-Smart Pro+
FDA 510(k) K233865 · Dentsply Sirona, Inc.
510(k) numberK233865
Submission
- Device name
- X-Smart Pro; X-Smart Pro+
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- December 6, 2023
- Decision date
- July 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was X-Smart Pro; X-Smart Pro+ cleared by the FDA?
X-Smart Pro; X-Smart Pro+ (K233865) received a 510(k) decision of Substantially Equivalent on July 24, 2024, 231 days after the submission was received.
What is the product code of K233865?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.