510(k) K253954
K253954 is an FDA 510(k) premarket notification submitted by X-Nav Technologies, LLC for the device "X-Guide Surgical Navigation System". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code QRY (Dental Navigation System), a Class II device regulated under 21 CFR 872.4120. X-Nav Technologies, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2026
- Date Received
- December 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Navigation System
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
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.