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FDA 510(k)

X-Smart Pro; X-Smart Pro+

K-Number: K233865 · 2024-07-24

ApplicantDentsply Sirona, Inc.
Decision Date2024-07-24
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-Smart Pro; X-Smart Pro+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) 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. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K233865.

When did X-Smart Pro; X-Smart Pro+ receive FDA 510(k) clearance?

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

Who is the listed applicant for X-Smart Pro; X-Smart Pro+?

The FDA 510(k) record lists Dentsply Sirona, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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