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X-Nav Technologies, LLC

United States·US-MF-000003234

Last updated September 18, 2026

About

X-Nav Knows Dental. X-Nav Knows Technology. We innovate to deliver solutions that we believe will help you practice better dentistry. X-Guide surgical navigation boasts dynamic 3D navigation.

From the manufacturer's own website. Source

What X-Nav Technologies, LLC makes

X-Nav Technologies, LLC produces surgical navigation systems for dental and craniofacial procedures, including the X-Guide platform for real-time 3D guidance during interventions. Their portfolio also includes non-bioabsorbable craniofacial bone screws and CAD/CAM dental milling systems for laboratory use, alongside specialized dental treatment software applications.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with listings in the FDA’s 510(k) and UDI databases, as well as in the EU’s eudamed registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 1555, Bustard Rd, Lansdale, United States
Website: x-navtech.com
LinkedIn: linkedin.com/company/x-nav-technologies-llc
Facebook: facebook.com/xnavtech
Email: [email protected]
Phone: +18554759628 (from company website)
PRRC Contact: Kimberly Chan
EUDAMED SRN: US-MF-000003234
FDA FEI Number: —
DUNS Number: —

Catalogue (142)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
X-Guide	P010727	FDA UDI	Class II	Active
X-Guide	P010721	FDA UDI	Class II	Active
X-Guide	P010874	FDA UDI	Class II	Unknown
X-Guide	P008296	FDA UDI	Class II	Active
X-Guide	P008697	FDA UDI	Class II	Active
X-Guide	P008542	FDA UDI	Class II	Active
X-Guide	P007842	FDA UDI	Class II	Active
X-Guide	P010726	FDA UDI	Class II	Active
X-Guide	P010720	FDA UDI	Class II	Active
X-Guide	P010815	FDA UDI	Class II	Active
X-Guide	P010873	FDA UDI	Class II	Unknown
X-Guide	P010859	FDA UDI	Class II	Active
X-Guide	P008810	FDA UDI	Class II	Active
X-Guide	P009186	FDA UDI	Class II	Active
BONE SCREW, EDX - 2.7Ø x 16mm - 2 ct.	P010922	EUDAMED	Class IIa	Active
BONE SCREW, EDX - 3.2Ø x 16mm - 2 ct.	P010925	EUDAMED	Class IIa	Active
BONE SCREW, EDX - 2.7Ø x 4mm - 2 ct.	P010920	EUDAMED	Class IIa	Active
X-Guide Surgical Navigation System	K192579	FDA 510(k)	Class II	Active
X-Guide Surgical Navigation System	K150222	FDA 510(k)	Class II	Active
X-Guide® Surgical Navigation System	K200662	FDA 510(k)	Class II	Active
X-Guide Surgical Navigation System	K232148	FDA 510(k)	Class II	Active
X-Guide® Surgical Navigation System	K211701	FDA 510(k)	Class II	Active
X-Guide Bone Screws	P008838	EUDAMED	Class IIa	Active
BONE SCREW - 2.0Ø x 4mm - 3 ct.	P008835	EUDAMED	Class IIa	Active
X-Guide System	P007839	EUDAMED	Class IIa	Active
BONE SCREW - 2.7Ø x 8mm - 3 ct.	P008842	EUDAMED	Class IIa	Active
BONE SCREW - 2.0Ø x 6mm - 3 ct.	P008836	EUDAMED	Class IIa	Active
BONE SCREW, EDX - 3.2Ø x 4mm - 2 ct.	P010923	EUDAMED	Class IIa	Active
X-Clip	P009083	EUDAMED	Class I	Active
X-Guide	P008843	EUDAMED	Class IIa	Active
BONE SCREW - 2.7Ø x 4mm - 3 ct.	P008840	EUDAMED	Class IIa	Active
BONE SCREW, EDX - 2.7Ø x 8mm - 2 ct.	P010921	EUDAMED	Class IIa	Active
BONE SCREW, EDX - 3.2Ø x 8mm - 2 ct.	P010924	EUDAMED	Class IIa	Active
X-Guide	P008838	EUDAMED	Class IIa	Active
EDX Bone Screw and Cap	P010920	EUDAMED	Class IIa	Active
BONE SCREW - 2.7Ø x 6mm - 3 ct.	P008841	EUDAMED	Class IIa	Active
BONE SCREW - 2.0Ø x 8mm - 3 ct.	P008837	EUDAMED	Class IIa	Active
X-Guide	P011000	EUDAMEDFDA UDI	Class IIa	Active
X-Guide	P008296	EUDAMEDFDA UDI	Class IIa	Active
X-Guide Bone Screws	P008836	EUDAMED	Class IIa	Active
FastMap	P011942	EUDAMEDFDA UDI	Class I	Active
EDX Bone Screw and Cap	P010923	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

X-Nav Technologies, LLC has four FDA recall records initiated between February 23, 2016, and March 4, 2024. The records include one classified, one open, and two terminated cases. Recalled items involve the X-Guide system’s X-Clip (PN P007665) due to potential issues with fiducial marker material, a Handpiece Adaptor with possible manufacturing defects affecting fit, and a probe tip with missing welds that could detach during use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 4, 2024	Z-1393-2024	—	open, classified	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.
Mar 4, 2024	Z-1392-2024	—	open, classified	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.
Sep 28, 2022	Z-0222-2023	—	open, classified	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.
Feb 23, 2016	Z-1391-2016	—	terminated	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 from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3