BACKGROUNDRegulatoryTier 1
FDA 510(k) K253954: X-Guide Surgical Navigation System
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices and DSOs that already use or are considering dynamic navigation for implants can now treat the X-Guide as a cleared alternative, potentially widening vendor options and competitive pricing.
Key points
- X-Nav Technologies received 510(k) clearance (K253954) for its X-Guide Surgical Navigation System, classified as Class 2 under 21 CFR 872.4120.
- Clearance is based on substantial equivalence to predicate devices, indicating the system meets FDA safety and performance benchmarks for dental surgical navigation.
- The product code QRY covers computer-assisted surgical systems used for precise implant osteotomy and placement.
- Clinics evaluating navigation technology now have an additional cleared platform to compare on accuracy, software updates, and service contracts.
Who should care
OwnerDSOSpecialist
Read the original on openFDA Dental Devices
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