Facility

X-NAV TECHNOLOGIES, LLC.

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011764595
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	1555 Bustard Road, Suite 75 & 110 Lansdale, PA, US 19446
Registration status	Active · expires 2026
Parent company	X-NAV Technologies, LLC. (owner-operator 10049672)
Brand names	IconiX AI; IconiX; X-Guide NXT; X-Guide; X-Guide System; X-Guide IconiX AI

Activity by year

Recalls (3)

Devices registered here (2)

Dental Navigation System
Product code QRY (opens in a new tab) · Class II · Dental · 21 CFR 872.4120
Dental Stereotaxic Instrument
Product code PLV (opens in a new tab) · Class II · Dental · 21 CFR 872.4120

Recalls & enforcement

Class IIOngoing2024-03-04
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.
Class IIOngoing2022-09-28
Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.
Class IITerminated2016-02-23
The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made…

All facilities operated by X-NAV Technologies, LLC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “X-NAV TECHNOLOGIES, LLC. (FEI 3011764595) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011764595-x-nav-technologies-llc/

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