# X-Guide P008542

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

- Canonical page: <https://devicerts.com/devices/x-guide-p008542-e5b76f9b>
- Manufacturer: [X-Nav Technologies, LLC](https://devicerts.com/manufacturers/x-nav-technologies-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: PLV, QRY
- GMDN: Surgical planning/navigation-enhancement system (61496)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00817421023361 · listed 2024-12-09 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K232148 · decision 2024-02-21 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K211701 · decision 2022-02-01 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K192579 · decision 2020-02-03 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K150222 · decision 2015-10-08 · decision SESE · status: Active · from GUDID

## 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.
- Z-0222-2023 · Class II · ongoing · initiated 2022-09-28: 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.
- Z-1391-2016 · Class II · terminated · initiated 2016-02-23: 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 from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3

## Identity

- Trade name: X-Guide [FDA GUDID (AccessGUDID)]
- Generic name: Surgical planning/navigation-enhancement system [FDA GUDID (AccessGUDID)]
- Model / reference: P008542 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00817421023361 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K150222 [FDA GUDID (AccessGUDID)]; K192579 [FDA GUDID (AccessGUDID)]; K211701 [FDA GUDID (AccessGUDID)]; K232148 [FDA GUDID (AccessGUDID)]
- FDA product code: PLV [FDA GUDID (AccessGUDID)]; QRY [FDA GUDID (AccessGUDID)]
- GMDN term: Surgical planning/navigation-enhancement system (61496) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 872.4120 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: X-Guide P008542, X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/x-guide-p008542-e5b76f9b (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/x-guide-p008542-e5b76f9b.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-p008542-e5b76f9b
- 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.