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X-Guide Surgical Navigation System

by X-Nav Technologies, LLC 4 variants

510(k) K232148

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232148↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK232148 Date21 Feb 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232148 decided 21 Feb 2024 Active
  • EUDAMED Active· +1 more in the status table

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1393-2024 FDA Class II initiated 4 Mar 2024
    • Ongoing Z-1392-2024 FDA Class II initiated 4 Mar 2024

    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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K232148
  2. Recall initiated FDA recalls Z-1393-2024
  3. Recall initiated FDA recalls Z-1392-2024

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
QRY
Device class
Class II
Regulation
21 CFR Part 872.4120
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K232148

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232148
UDI-DISize and differences
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022814 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022784 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022753 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421023361 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022838 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022920 —On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022821 —On the market
X-Guide P011803
X-Nav Technologies, LLC
P01180300817421022791 —On the market

Similar devices

Other devices filed under FDA product code QRY (Dental Navigation System).

Other devices from X-Nav Technologies, LLC

  • X-Guide P011265

    Class II

  • X-Guide P011266

    Class II

  • X-Guide P011268

    Class II

  • X-Guide P011271

    Class II

See all devices from X-Nav Technologies, LLC →