FDA 510(k)

X-Smart Pro; X-Smart Pro+

K-Number: K233865 · 2024-07-24

Decision Date2024-07-24

Product CodeEKX

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

X-Smart Pro; X-Smart Pro+ is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval number K233865. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Smart Pro; X-Smart Pro+?

X-Smart Pro; X-Smart Pro+ is a medical device that received FDA 510(k) clearance on 2024-07-24. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K233865.

When was X-Smart Pro; X-Smart Pro+ approved by the FDA?

X-Smart Pro; X-Smart Pro+ received FDA 510(k) clearance on 2024-07-24, under approval number K233865.

What company makes X-Smart Pro; X-Smart Pro+?

X-Smart Pro; X-Smart Pro+ is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for X-Smart Pro; X-Smart Pro+?

The FDA product code for X-Smart Pro; X-Smart Pro+ is EKX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.