# X-Guide Surgical Navigation System

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/x-guide-surgical-navigation-system-qry>
- Manufacturer: [X-Nav Technologies, LLC](https://devicerts.com/manufacturers/x-nav-technologies-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: QRY

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K232148 · decision 2024-02-21 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

- Z-1393-2024 · Class II · ongoing · initiated 2024-03-04: The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
- Z-1392-2024 · Class II · ongoing · initiated 2024-03-04: The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

## Identifiers

- 510(k) Number: K232148 [FDA 510(k)]
- FDA product code: QRY [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 872.4120 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: X-Guide Surgical Navigation System, X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/x-guide-surgical-navigation-system-qry (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/x-guide-surgical-navigation-system-qry.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/x-guide-surgical-navigation-system-qry
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.