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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
- facebook.com/xnavtech
- [email protected]
- Phone
- +18554759628 (from company website)
- PRRC Contact
- Kimberly Chan
- EUDAMED SRN
- US-MF-000003234
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (142)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| X-Guide | P010870 | FDA UDI | Class II | Active |
| X-Guide | P007640 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P010670 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P010813 | FDA UDI | Class II | Active |
| X-Guide | P010869 | FDA UDI | Class II | Active |
| X-Guide | P007463 | FDA UDI | Class II | Active |
| X-Guide | P010857 | FDA UDI | Class II | Active |
| X-Guide | P008819 | FDA UDI | Class II | Active |
| X-Guide | P009137 | FDA UDI | Class II | Unknown |
| X-Guide | P009350 | FDA UDI | Class II | Active |
| X-Guide | P008395 | FDA UDI | Class II | Active |
| X-Guide | P010812 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P008296 | FDA UDI | Class II | Active |
| X-Guide | P008802 | FDA UDI | Class II | Unknown |
| X-Guide | P009181 | FDA UDI | Class II | Active |
| X-Guide | P008886 | FDA UDI | Class II | Active |
| X-Guide | P010303 | FDA UDI | Class II | Active |
| X-Guide | P007461 | FDA UDI | Class II | Active |
| X-Guide | P010305 | FDA UDI | Class II | Active |
| X-Guide | P009154 | FDA UDI | Class II | Active |
| FastMap | P012003 | FDA UDI | Class II | Active |
| X-Guide | P008641 | FDA UDI | Class II | Active |
| X-Guide | P007464 | FDA UDI | Class II | Active |
| X-Guide | P010814 | FDA UDI | Class II | Active |
| X-Guide | P007750 | FDA UDI | Class II | Active |
| X-Guide | P008796 | FDA UDI | Class II | Active |
| X-Guide | P007737 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P010860 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P010702 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P010719 | FDA UDI | Class II | Active |
| X-Guide | P010307 | FDA UDI | Class II | Active |
| X-Guide | P007505 | FDA UDI | Class II | Active |
| X-Guide | P010729 | FDA UDI | Class II | Active |
| X-Guide | P008696 | FDA UDI | Class II | Active |
| X-Guide | P010949 | FDA UDI | Class II | Active |
| X-Guide | P008542 | FDA UDI | Class II | Active |
| X-Guide | P007749 | FDA UDI | Class II | Active |
| X-Guide | P010816 | FDA UDI | Class II | Active |
| X-Guide | P009587 | FDA UDI | Class II | Active |
| X-Guide | P007739 | FDA UDI | Class II | Active |
| X-Guide | P009586 | FDA UDI | Class II | Active |
| X-Guide | P010871 | FDA UDI | Class II | Active |
Related Companies
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Authorities
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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 |