Cleared Traditional

X-Smart Pro; X-Smart Pro+

K233865 · Dentsply Sirona, Inc. · Dental
Jul 2024
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K233865 is an FDA 510(k) clearance for the X-Smart Pro; X-Smart Pro+, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on July 24, 2024, 231 days after receiving the submission on December 6, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K233865 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2023
Decision Date July 24, 2024
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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