Dental
X-Guide Surgical Navigation System
X-Nav Technologies, LLC
FDA-cleared AI medical device
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
FDA Submission Metadata
- Submission number
- K232148
- Decision date
- February 2024
- FDA panel
- Dental
- Product code
- QRY
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.