X-Guide Surgical Navigation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192579 FDA 510(k)
- FDA Product Code
- PLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The X-Guide Surgical Navigation System is a dental stereotaxic instrument designed for precise surgical guidance in dental procedures. It integrates imaging and navigation technologies to assist clinicians in achieving accurate placement of dental implants and other interventions by providing real-time spatial orientation and alignment data.
This system is supplied as a reusable medical device and is intended for use in dental clinical settings. It is classified under device class II and adheres to regulatory standards including FDA 510(k) clearance, MDD, and MDR compliance. The device is not indicated for MRI use and requires proper storage and maintenance as per manufacturer guidelines to ensure functionality and sterility.
Frequently asked questions
What types of dental procedures is the X-Guide Surgical Navigation System designed to assist with?
The X-Guide Surgical Navigation System is specifically designed to assist with precise surgical guidance in dental procedures, particularly for achieving accurate placement of dental implants. It integrates imaging and navigation technologies to provide real-time spatial orientation and alignment data, helping clinicians improve the precision of interventions.
Is the X-Guide Surgical Navigation System reusable or single-use, and what does this mean for maintenance?
The X-Guide Surgical Navigation System is a reusable medical device. This means it must be properly cleaned, sterilized, and maintained according to the manufacturer’s guidelines to ensure functionality and sterility between uses. Reusability also implies that regular servicing may be required to sustain performance over time.
Can the X-Guide Surgical Navigation System be used in environments where MRI scans are performed, and why?
No, the X-Guide Surgical Navigation System is explicitly not indicated for use in MRI environments. This is because the device may contain metallic or electronic components that could interfere with MRI imaging or be affected by the magnetic fields, posing risks to both the device and patients.
How is the regulatory compliance of the X-Guide Surgical Navigation System established, and what standards does it meet?
The X-Guide Surgical Navigation System has undergone regulatory clearance through the FDA’s 510(k) process, demonstrating substantial equivalence to a predicate device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the EU, ensuring adherence to stringent safety and performance standards for dental stereotaxic instruments.
What should clinicians consider when storing the X-Guide Surgical Navigation System to ensure its proper function?
Clinicians should store the X-Guide Surgical Navigation System in a clean, dry environment protected from physical damage, extreme temperatures, and moisture. Since it is reusable, adherence to manufacturer guidelines for maintenance and sterilization is critical to preserve its accuracy and functionality. Avoid exposure to sources of electromagnetic interference, as this could compromise navigation performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192579 | Class II | Active |
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Manufacturer
- Manufacturer
- X-Nav Technologies, LLC
Sources (2)
- FDA 510(k) K192579 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026