X-Smart Pro; X-Smart Pro+— 510(k) K233865

Name: FDA 510(k) clearance K233865
Creator: U.S. Food and Drug Administration
Published: 2024-07-24

Substantially Equivalent

Dentsply Sirona, Inc.

FDA 510(k) clearance K233865 for X-Smart Pro; X-Smart Pro+, Substantially Equivalent on 2024-07-24. Applicant: Dentsply Sirona, Inc.. Device class: 1.

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2023-12-06
Decision date: 2024-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKX

view all

K261987 — Reusable SmartPeg2026-09-08
K252223 — Alpha Endo Handpiece (Alpha Endo)2025-10-16
K251597 — InnerView System2025-09-18
K243692 — EnDrive (EnDriveUS)2025-08-22
K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)2025-04-24

More clearances from Dentsply Sirona, Inc.

view all

K261935 — Surgical and Prosthetic Trays2026-09-04
K260722 — SureSmile Aligner (ASSY500020)2026-04-15
K253565 — SureSmile Software2026-03-04
K251614 — Stainless Steel Surgical Kits2026-02-06
K253009 — DS Core Detect2026-01-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.