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X-Guide Surgical Navigation System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232148

by X-Nav Technologies, LLC

Identifiers

510(k) Number
K232148 FDA 510(k)
FDA Product Code
QRY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4120 FDA 510(k)
Regulation Number
872.4120 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The X-Guide Surgical Navigation System is a Dental Navigation System, designed to assist in precise surgical planning and guidance for dental procedures. It integrates real-time imaging and tracking technologies to enhance accuracy during interventions such as implant placements or bone grafts, reducing operator reliance on manual measurements and improving procedural outcomes.

This system is supplied as a reusable medical device, intended for use in dental clinics and oral surgery settings. It operates in non-MRI environments and includes multiple registration numbers (3014552222, 3011874573, 3011764595, 3012787974) under FDA classification II (device class) and product code QRY. Authorized under FDA 510K clearance, MDD, and MDR compliance, it adheres to regulatory standards for dental surgical navigation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
X-Nav Technologies, LLC

Sources (2)

  • FDA 510(k) K232148 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026